Trial Outcomes & Findings for A New Method for Identifying Sensory Changes in Painful Chemotherapy-induced Peripheral Neuropathy (CIPN) (NCT NCT03687970)
NCT ID: NCT03687970
Last Updated: 2021-05-19
Results Overview
Comparison of the Aδ:C fiber detection threshold ratio (as measured by the DLss) between patients with painful neuropathy and patients who did not develop painful neuropathy following similar cancer chemotherapy
COMPLETED
NA
42 participants
At the time of the DLss (day 1)
2021-05-19
Participant Flow
This study was conducted at Washington University in St Louis School of Medicine. Participants were recruited between September 17, 2018, and September 17, 2019.
This is a case-control study. Case group: Patients with current symptoms of painful chemotherapy-induced peripheral neuropathy (CIPN) following treatment with oxaliplatin, cisplatin, paclitaxel, or docetaxel. Control group: patients who received the same chemotherapy agents, but who did not report current (or other long-term) painful CIPN.
Participant milestones
| Measure |
Group A: Painful Neuropathy Group
Patient with painful neuropathy after receiving treatment with oxaliplatin, cisplatin, paclitaxel or docetaxel
|
Group B: Control Group
Patient with no painful CIPN after receiving treatment with ...
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Group A: Painful Neuropathy Group
Patient with painful neuropathy after receiving treatment with oxaliplatin, cisplatin, paclitaxel or docetaxel
|
Group B: Control Group
Patient with no painful CIPN after receiving treatment with ...
|
|---|---|---|
|
Overall Study
visit scheduling conflicts
|
2
|
0
|
Baseline Characteristics
A New Method for Identifying Sensory Changes in Painful Chemotherapy-induced Peripheral Neuropathy (CIPN)
Baseline characteristics by cohort
| Measure |
Group A: Painful CIPN Group
n=20 Participants
Patients after chemotherapy with painful neuropathy
|
Group B: Control Group
n=20 Participants
Patients after chemotherapy without painful neuropathy
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
58.1 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
50.5 years
STANDARD_DEVIATION 14.5 • n=7 Participants
|
54.3 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At the time of the DLss (day 1)Population: Enrolled patients from control and case groups who completed Aδ:C fiber detection threshold ratio testing by DLss
Comparison of the Aδ:C fiber detection threshold ratio (as measured by the DLss) between patients with painful neuropathy and patients who did not develop painful neuropathy following similar cancer chemotherapy
Outcome measures
| Measure |
Group A: Painful Neuropathy Group
n=20 Participants
-patients after chemotherapy with painful CIPN who completed Aδ:C fiber detection threshold ratio testing by DLss.
|
Group B: Control Group
n=19 Participants
-patients after chemotherapy who did not report current (or other long-term) painful CIPN and completed Aδ:C fiber detection threshold ratio testing by DLss.
|
|---|---|---|
|
Aδ:C Fiber Detection Threshold Ratio
|
2.04 ratio
Standard Deviation 0.74
|
1.57 ratio
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: At the time of the DLss (day 1)Population: Aδ:C threshold ratios were measured among patients from both groups. Only patients who finished DLss testing for pain threshold determination were included in analysis.
Aδ:C pain threshold shows Aδ fiber threshold divided by C fiber threshold measured by DLss detection and pain threshold protocols.
Outcome measures
| Measure |
Group A: Painful Neuropathy Group
n=18 Participants
-patients after chemotherapy with painful CIPN who completed Aδ:C fiber detection threshold ratio testing by DLss.
|
Group B: Control Group
n=16 Participants
-patients after chemotherapy who did not report current (or other long-term) painful CIPN and completed Aδ:C fiber detection threshold ratio testing by DLss.
|
|---|---|---|
|
The Aδ:C Pain Threshold Ratio
|
1.95 ratio
Standard Deviation 0.71
|
1.60 ratio
Standard Deviation 0.42
|
SECONDARY outcome
Timeframe: At the time of the DLss (day 1)Population: Only patients who completed NPSI questionnaire were included in analysis.
The severity of painful CIPN on Neuropathic Pain Symptom Inventory (NPSI) scale. Increased NPSI (0-100) score indicates more severe neuropathic pain.
Outcome measures
| Measure |
Group A: Painful Neuropathy Group
n=20 Participants
-patients after chemotherapy with painful CIPN who completed Aδ:C fiber detection threshold ratio testing by DLss.
|
Group B: Control Group
n=20 Participants
-patients after chemotherapy who did not report current (or other long-term) painful CIPN and completed Aδ:C fiber detection threshold ratio testing by DLss.
|
|---|---|---|
|
The Severity of Neuropathy on NPSI Scale.
|
32.60 score on a scale
Standard Deviation 19.89
|
0.2 score on a scale
Standard Deviation 0.7
|
Adverse Events
Group A: Painful CIPN Group
Group B: Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A: Painful CIPN Group
n=20 participants at risk
All patients who were enrolled in the Case group and completed any testing
|
Group B: Control Group
n=20 participants at risk
All patients who were enrolled in the Control group and completed any testing
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
5.0%
1/20 • Number of events 1 • Since study activities included relatively safe testings conducted within a day the safety data were actively collected during study visit day. Patients were informed to report any adverse effects throughout the study visit day, and by telephone any time after the study visit.
any unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease.
|
0.00%
0/20 • Since study activities included relatively safe testings conducted within a day the safety data were actively collected during study visit day. Patients were informed to report any adverse effects throughout the study visit day, and by telephone any time after the study visit.
any unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease.
|
Additional Information
Simon Haroutounian, PhD. Assistant Professor,
Washington University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place