Trial Outcomes & Findings for Biomarkers in Chemotherapy-Induced Peripheral Neurotoxicity (NCT NCT03348956)
NCT ID: NCT03348956
Last Updated: 2024-06-20
Results Overview
EPR Oximetry will measure tissue oxygen levels in the injected foot during 10 minutes of breathing room air, 10 minutes while breathing 100% oxygen, and 10 minutes of room air.
COMPLETED
NA
7 participants
Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)
2024-06-20
Participant Flow
Participant milestones
| Measure |
EPR Oximetry
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points (pre-exposure, during-exposure or CIPN incidence, and post exposure), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have up to five EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
Clinical, Electrophysiologic Metrics, and Neuropathy Scales
|
7
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
EPR Oximetry
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points (pre-exposure, during-exposure or CIPN incidence, and post exposure), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have up to five EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=7 Participants
|
|
Body Mass Index (BMI)
|
30.5 kg/m2
STANDARD_DEVIATION 6.6 • n=7 Participants
|
PRIMARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Population: 3 patients underwent testing. 1 patient did not undergo the 100% oxygen condition at the End of Chemo, so there is no data for Mid-Point or recovery for that patient. Data was not gathered for the remaining 4 participants.
EPR Oximetry will measure tissue oxygen levels in the injected foot during 10 minutes of breathing room air, 10 minutes while breathing 100% oxygen, and 10 minutes of room air.
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=3 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
n=3 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
n=3 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Relative Change in % pO2
Mid-Point
|
12.3 change in % oxygenation
Interval -7.0 to 45.0
|
19 change in % oxygenation
Interval -25.0 to 44.0
|
24 change in % oxygenation
Interval 11.0 to 44.0
|
|
Relative Change in % pO2
End of Chemo
|
25.3 change in % oxygenation
Interval 20.0 to 32.0
|
9.5 change in % oxygenation
Interval 4.0 to 15.0
|
42.5 change in % oxygenation
Interval 39.0 to 46.0
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. MRC scale for muscle strength (0-5) Grade 5: Normal Grade 4: Movement against gravity and resistance Grade 3: Movement against gravity over (almost) the full range Grade 2: Movement of the limb but not against gravity Grade 1: Visible contraction without movement of the limb (not existent for hip flexion) Grade 0: No visible contraction
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Neurologic Examination_ Strength_ Toe Fan
Post
|
4.89 Units on a scale
Standard Deviation 0.27
|
—
|
—
|
|
Neurologic Examination_ Strength_ Toe Fan
Pre
|
5 Units on a scale
Standard Deviation 0
|
—
|
—
|
|
Neurologic Examination_ Strength_ Toe Fan
Mid
|
4.98 Units on a scale
Standard Deviation 0.06
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. MRC scale for muscle strength (0-5) Grade 5: Normal Grade 4: Movement against gravity and resistance Grade 3: Movement against gravity over (almost) the full range Grade 2: Movement of the limb but not against gravity Grade 1: Visible contraction without movement of the limb (not existent for hip flexion) Grade 0: No visible contraction
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Neurologic Examination_ Strength_ Toe Flex
Pre
|
5 Units on a scale
Standard Deviation 0
|
—
|
—
|
|
Neurologic Examination_ Strength_ Toe Flex
Mid
|
4.98 Units on a scale
Standard Deviation 0.06
|
—
|
—
|
|
Neurologic Examination_ Strength_ Toe Flex
Post
|
4.89 Units on a scale
Standard Deviation 0.31
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. MRC scale for muscle strength (0-5) Grade 5: Normal Grade 4: Movement against gravity and resistance Grade 3: Movement against gravity over (almost) the full range Grade 2: Movement of the limb but not against gravity Grade 1: Visible contraction without movement of the limb (not existent for hip flexion) Grade 0: No visible contraction
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Neurologic Examination_ Strength_ Inv
Pre
|
5 Units on a scale
Standard Deviation 0
|
—
|
—
|
|
Neurologic Examination_ Strength_ Inv
Mid
|
4.96 Units on a scale
Standard Deviation 0.09
|
—
|
—
|
|
Neurologic Examination_ Strength_ Inv
Post
|
4.96 Units on a scale
Standard Deviation 0.09
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. MRC scale for muscle strength (0-5) Grade 5: Normal Grade 4: Movement against gravity and resistance Grade 3: Movement against gravity over (almost) the full range Grade 2: Movement of the limb but not against gravity Grade 1: Visible contraction without movement of the limb (not existent for hip flexion) Grade 0: No visible contraction
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Neurologic Examination_ Strength_ Ev
Pre
|
5 Units on a scale
Standard Deviation 0
|
—
|
—
|
|
Neurologic Examination_ Strength_ Ev
Mid
|
4.96 Units on a scale
Standard Deviation 0.09
|
—
|
—
|
|
Neurologic Examination_ Strength_ Ev
Post
|
4.96 Units on a scale
Standard Deviation 0.09
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. MRC scale for muscle strength (0-5) Grade 5: Normal Grade 4: Movement against gravity and resistance Grade 3: Movement against gravity over (almost) the full range Grade 2: Movement of the limb but not against gravity Grade 1: Visible contraction without movement of the limb (not existent for hip flexion) Grade 0: No visible contraction
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Neurologic Examination_ Strength_ ADF
Pre
|
5 Units on a scale
Standard Deviation 0
|
—
|
—
|
|
Neurologic Examination_ Strength_ ADF
Mid
|
5 Units on a scale
Standard Deviation 0
|
—
|
—
|
|
Neurologic Examination_ Strength_ ADF
Post
|
5 Units on a scale
Standard Deviation 0
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. The position of the intersect is recorded on an arbitrary scale from 0 to 8 on a Rydel-Seiffer tuning fork once the subject is no longer perceiving vibration. The higher the number, the better the vibratory sense.
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Neurologic Examination_ Vibration Sense_Toe
Post
|
4.53 Units on a scale
Standard Deviation 2.09
|
—
|
—
|
|
Neurologic Examination_ Vibration Sense_Toe
Pre
|
6.71 Units on a scale
Standard Deviation 0.82
|
—
|
—
|
|
Neurologic Examination_ Vibration Sense_Toe
Mid
|
4.66 Units on a scale
Standard Deviation 3.10
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. The position of the intersect is recorded on an arbitrary scale from 0 to 8 on a Rydel-Seiffer tuning fork once the subject is no longer perceiving vibration. The higher the number, the better the vibratory sense.
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Neurologic Examination_ Vibration Sense_MM
Pre
|
6.73 Units on a scale
Standard Deviation 0.80
|
—
|
—
|
|
Neurologic Examination_ Vibration Sense_MM
Post
|
5.78 Units on a scale
Standard Deviation 1.20
|
—
|
—
|
|
Neurologic Examination_ Vibration Sense_MM
Mid
|
6.44 Units on a scale
Standard Deviation 1.01
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. The position of the intersect is recorded on an arbitrary scale from 0 to 8 on a Rydel-Seiffer tuning fork once the subject is no longer perceiving vibration. The higher the number, the better the vibratory sense.
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Neurologic Examination_ Vibration Sense_Knee
Pre
|
6.96 Units on a scale
Standard Deviation 0.86
|
—
|
—
|
|
Neurologic Examination_ Vibration Sense_Knee
Mid
|
7 Units on a scale
Standard Deviation 0.98
|
—
|
—
|
|
Neurologic Examination_ Vibration Sense_Knee
Post
|
6.10 Units on a scale
Standard Deviation 0.68
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. The position of the intersect is recorded on an arbitrary scale from 0 to 8 on a Rydel-Seiffer tuning fork once the subject is no longer perceiving vibration. The higher the number, the better the vibratory sense.
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Neurologic Examination_ Vibration Sense_DIP2
Pre
|
7.82 Units on a scale
Standard Deviation 0.46
|
—
|
—
|
|
Neurologic Examination_ Vibration Sense_DIP2
Mid
|
7.78 Units on a scale
Standard Deviation 0.57
|
—
|
—
|
|
Neurologic Examination_ Vibration Sense_DIP2
Post
|
7.53 Units on a scale
Standard Deviation 0.66
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. The position of the intersect is recorded on an arbitrary scale from 0 to 8 on a Rydel-Seiffer tuning fork once the subject is no longer perceiving vibration. The higher the number, the better the vibratory sense.
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Neurologic Examination_ Vibration Sense_DIP5
Pre
|
7.72 Units on a scale
Standard Deviation 0.61
|
—
|
—
|
|
Neurologic Examination_ Vibration Sense_DIP5
Mid
|
7.76 Units on a scale
Standard Deviation 0.57
|
—
|
—
|
|
Neurologic Examination_ Vibration Sense_DIP5
Post
|
7.60 Units on a scale
Standard Deviation 0.59
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. REFLEX SCALE for Deep Tendon Reflexes (DTRs) The score ranges from 0 - 9, where 0 is no reflex response (areflexia)/always abnormal, greater than 1 and less than 3 is normal, and 9 is a tap that elicits a repeating reflex (clonus)/always abnormal.
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Neurologic Examination_ Deep Tendon Reflexes _ Biceps
Pre
|
4.42 Units on a scale
Standard Deviation 0.51
|
—
|
—
|
|
Neurologic Examination_ Deep Tendon Reflexes _ Biceps
Mid
|
3.28 Units on a scale
Standard Deviation 1.89
|
—
|
—
|
|
Neurologic Examination_ Deep Tendon Reflexes _ Biceps
Post
|
2.14 Units on a scale
Standard Deviation 1.61
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. REFLEX SCALE for Deep Tendon Reflexes (DTRs) The score ranges from 0 - 9, where 0 is no reflex response (areflexia)/always abnormal, greater than 1 and less than 3 is normal, and 9 is a tap that elicits a repeating reflex (clonus)/always abnormal.
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Neurologic Examination_ Deep Tendon Reflexes _ Triceps
Pre
|
4.14 Units on a scale
Standard Deviation 1.02
|
—
|
—
|
|
Neurologic Examination_ Deep Tendon Reflexes _ Triceps
Mid
|
3.14 Units on a scale
Standard Deviation 1.74
|
—
|
—
|
|
Neurologic Examination_ Deep Tendon Reflexes _ Triceps
Post
|
2.57 Units on a scale
Standard Deviation 1.78
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. REFLEX SCALE for Deep Tendon Reflexes (DTRs) The score ranges from 0 - 9, where 0 is no reflex response (areflexia)/always abnormal, greater than 1 and less than 3 is normal, and 9 is a tap that elicits a repeating reflex (clonus)/always abnormal.
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Neurologic Examination_ Deep Tendon Reflexes _ BR
Pre
|
4.21 Units on a scale
Standard Deviation 0.57
|
—
|
—
|
|
Neurologic Examination_ Deep Tendon Reflexes _ BR
Mid
|
3.28 Units on a scale
Standard Deviation 1.54
|
—
|
—
|
|
Neurologic Examination_ Deep Tendon Reflexes _ BR
Post
|
1.92 Units on a scale
Standard Deviation 1.32
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. REFLEX SCALE for Deep Tendon Reflexes (DTRs) The score ranges from 0 - 9, where 0 is no reflex response (areflexia)/always abnormal, greater than 1 and less than 3 is normal, and 9 is a tap that elicits a repeating reflex (clonus)/always abnormal.
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Neurologic Examination_ Deep Tendon Reflexes _ Patella
Pre
|
4 units on a scale
Standard Deviation 0.67
|
—
|
—
|
|
Neurologic Examination_ Deep Tendon Reflexes _ Patella
Mid
|
3.28 units on a scale
Standard Deviation 1.13
|
—
|
—
|
|
Neurologic Examination_ Deep Tendon Reflexes _ Patella
Post
|
2.71 units on a scale
Standard Deviation 1.63
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. REFLEX SCALE for Deep Tendon Reflexes (DTRs) The score ranges from 0 - 9, where 0 is no reflex response (areflexia)/always abnormal, greater than 1 and less than 3 is normal, and 9 is a tap that elicits a repeating reflex (clonus)/always abnormal.
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Neurologic Examination_ Deep Tendon Reflexes _ Achilles
Pre
|
4.14 units on a scale
Standard Deviation 0.77
|
—
|
—
|
|
Neurologic Examination_ Deep Tendon Reflexes _ Achilles
Mid
|
1.57 units on a scale
Standard Deviation 1.78
|
—
|
—
|
|
Neurologic Examination_ Deep Tendon Reflexes _ Achilles
Post
|
1 units on a scale
Standard Deviation 1.35
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Mean Nerve Conduction Metrics (Amplitude)_DORSAL SURAL
Pre
|
6.2 uV
Standard Deviation 8.8
|
—
|
—
|
|
Mean Nerve Conduction Metrics (Amplitude)_DORSAL SURAL
Mid
|
6.3 uV
Standard Deviation 7.7
|
—
|
—
|
|
Mean Nerve Conduction Metrics (Amplitude)_DORSAL SURAL
Post
|
3.5 uV
Standard Deviation 4.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Change in Nerve Conduction Metrics (Amplitude)_MED PLANTAR
Pre
|
7.5 uV
Standard Deviation 7.2
|
—
|
—
|
|
Change in Nerve Conduction Metrics (Amplitude)_MED PLANTAR
Mid
|
6.4 uV
Standard Deviation 7.1
|
—
|
—
|
|
Change in Nerve Conduction Metrics (Amplitude)_MED PLANTAR
Post
|
5.7 uV
Standard Deviation 6.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Change in Nerve Conduction Metrics (Amplitude)_SURAL
Pre
|
21.9 uV
Standard Deviation 13.1
|
—
|
—
|
|
Change in Nerve Conduction Metrics (Amplitude)_SURAL
Mid
|
16.6 uV
Standard Deviation 7.0
|
—
|
—
|
|
Change in Nerve Conduction Metrics (Amplitude)_SURAL
Post
|
19.5 uV
Standard Deviation 13.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Population: Pre-Mid- is prior to chemotherapy exposure Pre-Post- is one week or more after chemotherapy completion
Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. The outcome measure is reporting the average of the differences in amplitudes Pre-Mid and Pre-Post exposure (for example, the change from Pre and Mid is calculated, and then the change across all participants is averaged).
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Mean of the Difference in Nerve Conduction Amplitudes Between Pre-Mid and Pre-Post exposure_Dorsal Sural
Pre-Mid-Mean
|
-0.47 uV
Interval -2.3 to 1.0
|
—
|
—
|
|
Mean of the Difference in Nerve Conduction Amplitudes Between Pre-Mid and Pre-Post exposure_Dorsal Sural
Pre-Post-Mean
|
-3.87 uV
Interval -10.7 to 0.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Population: Pre-Mid- is prior to chemotherapy exposure Pre-Post- is one week or more after chemotherapy completion
Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Change in Nerve Conduction/Mixed Nerve Amplitudes _Medial Plantar
Pre-Mid-Mean
|
-1.0 uV
Interval -7.8 to 3.6
|
—
|
—
|
|
Change in Nerve Conduction/Mixed Nerve Amplitudes _Medial Plantar
Pre-Post-Mean
|
-1.7 uV
Interval -13.7 to 3.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Population: Pre-Mid- is prior to chemotherapy exposure Pre-Post- is one week or more after chemotherapy completion
Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Change in Nerve Conduction/Mixed Nerve Amplitudes _Sural
Pre-Mid-Mean
|
-5.2 uV
Interval -24.3 to 6.5
|
—
|
—
|
|
Change in Nerve Conduction/Mixed Nerve Amplitudes _Sural
Pre-Post-Mean
|
-2.3 uV
Interval -9.5 to 6.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Change in Nerve Conduction_Motor_ (Amplitude)_Peron-EDB
Pre
|
4.6 mV
Standard Deviation 1.1
|
—
|
—
|
|
Change in Nerve Conduction_Motor_ (Amplitude)_Peron-EDB
Mid
|
3.4 mV
Standard Deviation 1.9
|
—
|
—
|
|
Change in Nerve Conduction_Motor_ (Amplitude)_Peron-EDB
Post
|
3.4 mV
Standard Deviation 2.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Change in Nerve Conduction_Motor_ (Amplitude)_Peron-TA
Pre
|
5.2 mV
Standard Deviation 1.4
|
—
|
—
|
|
Change in Nerve Conduction_Motor_ (Amplitude)_Peron-TA
Mid
|
5.1 mV
Standard Deviation 1.3
|
—
|
—
|
|
Change in Nerve Conduction_Motor_ (Amplitude)_Peron-TA
Post
|
5.1 mV
Standard Deviation 1.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Change in Nerve Conduction_Motor_ (Amplitude)_Tibial-AH
Pre
|
9.2 mV
Standard Deviation 3.9
|
—
|
—
|
|
Change in Nerve Conduction_Motor_ (Amplitude)_Tibial-AH
Mid
|
9.0 mV
Standard Deviation 5.7
|
—
|
—
|
|
Change in Nerve Conduction_Motor_ (Amplitude)_Tibial-AH
Post
|
10.1 mV
Standard Deviation 6.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Population: For the dorsal sural sensory nerve, a change in mean velocity pre-chemotherapy to mid-chemotherapy is reported as well as the change in mean velocity for pre-chemotherapy to post-chemotherapy
Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Peroneal CMAP AMP, EDB
Pre-Mid
|
-1.1 m/s
Interval -3.9 to 0.5
|
—
|
—
|
|
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Peroneal CMAP AMP, EDB
Pre-Post
|
-1.4 m/s
Interval -4.6 to 0.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Population: For the dorsal sural sensory nerve, a change in mean velocity pre-chemotherapy to mid-chemotherapy is reported as well as the change in mean velocity for pre-chemotherapy to post-chemotherapy
Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Peroneal CMAP, AT
Pre-Mid
|
0 m/s
Interval -1.6 to 3.8
|
—
|
—
|
|
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Peroneal CMAP, AT
Pre-Post
|
0 m/s
Interval -2.8 to 5.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Population: For the dorsal sural sensory nerve, a change in mean velocity pre-chemotherapy to mid-chemotherapy is reported as well as the change in mean velocity for pre-chemotherapy to post-chemotherapy
Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Tibial CMAP, AH
Pre-Mid
|
-0.2 m/s
Interval -4.4 to 3.3
|
—
|
—
|
|
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Tibial CMAP, AH
Pre-Post
|
0.9 m/s
Interval -1.6 to 7.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Population: For the dorsal sural sensory nerve, a change in mean velocity pre-chemotherapy to mid-chemotherapy is reported as well as the change in mean velocity for pre-chemotherapy to post-chemotherapy
Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Dorsal Sural CV
Pre-Mid
|
1.8 m/s
Interval -4.0 to 13.8
|
—
|
—
|
|
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Dorsal Sural CV
Pre-Post
|
-1.5 m/s
Interval -6.0 to 2.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Population: For the Med Plantar sensory nerve, a change in mean velocity pre-chemotherapy to mid-chemotherapy is reported as well as the change in mean velocity for pre-chemotherapy to post-chemotherapy
Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Med Plantar CV
Pre-Mid
|
-1.2 m/s
Interval -9.6 to 4.3
|
—
|
—
|
|
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Med Plantar CV
Pre-Post
|
-3.5 m/s
Interval -18.7 to 3.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Population: For the Sural sensory nerve, a change in mean velocity pre-chemotherapy to mid-chemotherapy is reported as well as the change in mean velocity for pre-chemotherapy to post-chemotherapy
Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Sural CV
Pre-Mid
|
2.7 m/s
Interval -5.5 to 11.0
|
—
|
—
|
|
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Sural CV
Pre-Post
|
0.3 m/s
Interval -10.6 to 9.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Population: For the Peroneal CV, distal sensory nerve, a change in mean velocity pre-chemotherapy to mid-chemotherapy is reported as well as the change in mean velocity for pre-chemotherapy to post-chemotherapy
Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy.
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Peroneal CV, Distal
Pre-Mid
|
1.6 m/s
Interval -2.0 to 4.5
|
—
|
—
|
|
Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Peroneal CV, Distal
Pre-Post
|
-2.2 m/s
Interval -8.3 to 4.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion.
Neuropathy-Specific Quality of Life scale measuring Positive Affect and Well Being The range in score is 23 to 115, with a low score indicating a less positive affect and well-being
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Mean Score of Neuro-Quality of Life - Positive Affect and Well-Being Scale
Pre
|
93.9 score on a scale
Standard Deviation 21.5
|
—
|
—
|
|
Mean Score of Neuro-Quality of Life - Positive Affect and Well-Being Scale
Mid
|
96.3 score on a scale
Standard Deviation 17.4
|
—
|
—
|
|
Mean Score of Neuro-Quality of Life - Positive Affect and Well-Being Scale
Post
|
100.6 score on a scale
Standard Deviation 17.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
Neuropathy-Specific Quality of Life scale measuring Satisfaction with Social Roles and Activities The range in scores is 47 to 235, with a lower score indicating less satisfaction with social roles and activities
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Mean Score of Neuro-Quality of Life - Satisfaction With Social Roles and Activities Scale
Post
|
187.6 score on a scale
Standard Deviation 50.0
|
—
|
—
|
|
Mean Score of Neuro-Quality of Life - Satisfaction With Social Roles and Activities Scale
Pre
|
172.9 score on a scale
Standard Deviation 46.4
|
—
|
—
|
|
Mean Score of Neuro-Quality of Life - Satisfaction With Social Roles and Activities Scale
Mid
|
187.1 score on a scale
Standard Deviation 33.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
Neuropathy-Specific Quality of Life scale measuring Lower Extremity Function (Mobility) The range in scores is 19 to 95, with a lower score indicating more difficulty with lower extremity function
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Mean Score of Neuro-Quality of Life - Lower Extremity Function (Mobility) Scale
Pre
|
89.1 score on a scale
Standard Deviation 10.1
|
—
|
—
|
|
Mean Score of Neuro-Quality of Life - Lower Extremity Function (Mobility) Scale
Mid
|
90.6 score on a scale
Standard Deviation 7.1
|
—
|
—
|
|
Mean Score of Neuro-Quality of Life - Lower Extremity Function (Mobility) Scale
Post
|
91.4 score on a scale
Standard Deviation 5.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
Neuropathy-Specific Quality of Life scale measuring Upper Extremity Function (Fine Motor, Activities of Daily Living) The range in scores is 20 to 100, with a low score indicating more difficulty with upper extremity function
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Mean Score of Neuro-Quality of Life - Upper Extremity Function (Fine Motor, Activities of Daily Living) Scale
Pre
|
97.0 score on a scale
Standard Deviation 5.5
|
—
|
—
|
|
Mean Score of Neuro-Quality of Life - Upper Extremity Function (Fine Motor, Activities of Daily Living) Scale
Mid
|
99.3 score on a scale
Standard Deviation 1.5
|
—
|
—
|
|
Mean Score of Neuro-Quality of Life - Upper Extremity Function (Fine Motor, Activities of Daily Living) Scale
Post
|
97.9 score on a scale
Standard Deviation 4.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
Neuropathy Total Symptom Score questionnaire with 6 questions The range is scores is 0 to 22 with a higher score indicating worse symptoms
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Mean Score of The Neuropathy Total Symptom Score-6 Questionnaire
Pre
|
0.3 score on a scale
Standard Deviation 0.5
|
—
|
—
|
|
Mean Score of The Neuropathy Total Symptom Score-6 Questionnaire
Mid
|
2.2 score on a scale
Standard Deviation 1.8
|
—
|
—
|
|
Mean Score of The Neuropathy Total Symptom Score-6 Questionnaire
Post
|
3.1 score on a scale
Standard Deviation 3.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
Toronto Clinical Neuropathy Scoring System The range in scores is 0 to 19 with higher scores indicating worse neuropathy
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Mean Score of Toronto Clinical Neuropathy Scoring System
Pre
|
2.1 score on a scale
Standard Deviation 2.0
|
—
|
—
|
|
Mean Score of Toronto Clinical Neuropathy Scoring System
Mid
|
5.3 score on a scale
Standard Deviation 3.4
|
—
|
—
|
|
Mean Score of Toronto Clinical Neuropathy Scoring System
Post
|
5.0 score on a scale
Standard Deviation 3.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
National Cancer Insitute - Common Toxicity Criteria The range in scores is 0 to 5, with higher scores indicating worse toxicity
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Mean Score of National Cancer Institute - Common Toxicity Criteria
Pre
|
0.3 score on a scale
Standard Deviation 0.8
|
—
|
—
|
|
Mean Score of National Cancer Institute - Common Toxicity Criteria
Mid
|
0.7 score on a scale
Standard Deviation 1.0
|
—
|
—
|
|
Mean Score of National Cancer Institute - Common Toxicity Criteria
Post
|
1.4 score on a scale
Standard Deviation 0.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
Total Neuropathy score The range in scores is 0 to 40, with higher scores indicating worse neuropathy
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Mean Score of Total Neuropathy Scores
Pre
|
1.3 score on a scale
Standard Deviation 1.1
|
—
|
—
|
|
Mean Score of Total Neuropathy Scores
Mid
|
6.0 score on a scale
Standard Deviation 5.0
|
—
|
—
|
|
Mean Score of Total Neuropathy Scores
Post
|
8.1 score on a scale
Standard Deviation 6.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
Survey of Autonomic Symptoms, questions in Column B The range in scores is 0 to 55 for women and 0 to 60 for men, with higher scores indicating more bothersome symptoms
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Mean Score of Survey of Autonomic Symptoms, Column B
Pre
|
5.9 score on a scale
Standard Deviation 3.7
|
—
|
—
|
|
Mean Score of Survey of Autonomic Symptoms, Column B
Mid
|
6.9 score on a scale
Standard Deviation 4.9
|
—
|
—
|
|
Mean Score of Survey of Autonomic Symptoms, Column B
Post
|
5.2 score on a scale
Standard Deviation 3.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
McGill Visual Analog Scale for Pain The range in scores is 0 to 100, with 0 indicting "No pain" and 100 indicating "Worst pain possible"
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Mean Score of McGill Pain Visual Analog Scale
Pre
|
21.0 score on a scale
Standard Deviation 23.8
|
—
|
—
|
|
Mean Score of McGill Pain Visual Analog Scale
Mid
|
27.9 score on a scale
Standard Deviation 25.5
|
—
|
—
|
|
Mean Score of McGill Pain Visual Analog Scale
Post
|
27.3 score on a scale
Standard Deviation 30.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
Short Form McGill Pain Questionnaire The range in scores is 0 to 15, with higher scores indicating worse pain
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Mean Scores of Short Form McGill Pain Questionnaire
Pre
|
3.3 score on a scale
Standard Deviation 4.0
|
—
|
—
|
|
Mean Scores of Short Form McGill Pain Questionnaire
Mid
|
2.4 score on a scale
Standard Deviation 2.1
|
—
|
—
|
|
Mean Scores of Short Form McGill Pain Questionnaire
Post
|
2.3 score on a scale
Standard Deviation 1.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline)Population: Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion
Survey of Autonomic Symptoms, questions in column A The range in scores is 0 to 11 for women and 0 to 12 for men, with higher scores indicating more symptoms
Outcome measures
| Measure |
Relative % pO2 Change From Baseline While Breathing Room Air
n=7 Participants
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing 100% Oxygen
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
Relative % pO2 Change From Baseline While Breathing Room Air (Recovery)
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|---|---|
|
Mean Score of Survey of Autonomic Symptoms, Column A
Post
|
2.0 score on a scale
Standard Deviation 1.4
|
—
|
—
|
|
Mean Score of Survey of Autonomic Symptoms, Column A
Pre
|
2.4 score on a scale
Standard Deviation 1.1
|
—
|
—
|
|
Mean Score of Survey of Autonomic Symptoms, Column A
Mid
|
2.3 score on a scale
Standard Deviation 0.8
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Samples were never gathered due to no participants enrolled after protocol was amended to include the collection of serum NF-L.
Changes in serum NFL levels over the course of chemotherapy will be monitored to determine if NFL can be used as a biomarker for axonal damage in patients who develop CIPN. NFL will be measured at baseline, before each round of chemotherapy and at the completion of chemotherapy. Changes in NFL will be compared between patients who develop CIPN and those that do not.
Outcome measures
Outcome data not reported
Adverse Events
EPR Oximetry
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
EPR Oximetry
n=7 participants at risk
All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points (pre-exposure, during-exposure or CIPN incidence, and post exposure), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing.
EPR Oximetry: Subjects will have up to five EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
|
|---|---|
|
General disorders
Dysphagia
|
28.6%
2/7 • Number of events 2 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
High WBC w/o infection
|
42.9%
3/7 • Number of events 3 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Thrush on tongue
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Low K+ Lab
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Diverticulitis
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Shortness of breath
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
left ankle swelling-occasional
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Pain during urination
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Worsening Appetite
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
Vascular disorders
Erythema
|
28.6%
2/7 • Number of events 2 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Nausea
|
42.9%
3/7 • Number of events 3 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Increased symptoms of reflux
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Abnormal Lab Values
|
28.6%
2/7 • Number of events 2 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
Gastrointestinal disorders
Diarrhea
|
28.6%
2/7 • Number of events 2 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
High LFT's
|
28.6%
2/7 • Number of events 2 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Increased Fatigue
|
42.9%
3/7 • Number of events 3 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Soreness in both walls along MRM incision
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
Nervous system disorders
CIPN
|
71.4%
5/7 • Number of events 5 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Redness/Itchy on scalp
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Cramping in calves- severe
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Discomfort in anterior aspect of shins
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Decreased Dexterity
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Increased unsteadiness
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Chest Pain
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Indigestion
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Headache
|
28.6%
2/7 • Number of events 2 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Sore Throat due to Nocturnal Epistaxis
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Alopecia
|
42.9%
3/7 • Number of events 3 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Anemia-Mild
|
28.6%
2/7 • Number of events 2 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Knee Pain
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Pain up to hip from knee
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Shingles
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Cellulitis
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Bloating
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Dry Mouth
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Hyperhidrosis
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Brief periods of heart pounding
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Aches, Cramps and Spasms
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Sore on tip of tongue
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Brief burning sensation on chest, back, and legs
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Low grade fever
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Ecchymosis
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Bilateral ankle swelling
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Myalgia
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Cytopenia
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Discomfort at Injection Site
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Right Hip/Lower back pain
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Myalgias
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Fever
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Mild Cough
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Mild Anemia
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Arthralgias
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Dysgeusia
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Acute Pharyngitis
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Pain at injection site
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Purple Hematoma at injection site
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Rash-under Arm Pit
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Redness along hands and wrists
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Mouth Sore
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Tearing of eyes
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
|
General disorders
Allergic Reaction
|
14.3%
1/7 • Number of events 1 • Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place