Trial Outcomes & Findings for Ultrasound in Detecting Taxane-Induced Neuropathy in Patients With Breast Cancer (NCT NCT03139435)
NCT ID: NCT03139435
Last Updated: 2024-04-08
Results Overview
Will be determined by ultrasound in the tibial nerve. Will be compared to the historical data from healthy patients using two-sample t-test (two-sample t-test selected as primary data from the historical control patients is available and will be used for analysis). Will also compare the nerve cross-sectional area in our study sample to that in the historical diabetic neuropathy patients and historical oxaliplatin neuropathy patients using one-sample t-test. The general linear model will be used to evaluate any factors (e.g., age) that may be associated with the nerve cross-sectional area. Due
COMPLETED
NA
20 participants
Up to 30 days
2024-04-08
Participant Flow
Historical control information is a reference group only and were not active participants in this trial.
Unit of analysis: nerve samples
Participant milestones
| Measure |
Case
Study sample
|
Historical Control
Historical Control group - not part of study enrollment
|
|---|---|---|
|
Overall Study
STARTED
|
20 20
|
60 120
|
|
Overall Study
COMPLETED
|
20 20
|
60 120
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ultrasound in Detecting Taxane-Induced Neuropathy in Patients With Breast Cancer
Baseline characteristics by cohort
| Measure |
Case
n=20 nerve samples
Study sample
|
Control (From Another Study)
n=120 nerve samples
These patients were not enrolled as part of this study. This data comes from another study. Each of these n=60 patients had tests done on both left and right arms, which creates the n=120 samples found in the results.
|
Total
n=140 nerve samples
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.5 years
n=5 Participants
|
45.9 years
n=7 Participants
|
48.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 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
|
0 Participants
n=7 Participants
|
0 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
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 30 daysWill be determined by ultrasound in the tibial nerve. Will be compared to the historical data from healthy patients using two-sample t-test (two-sample t-test selected as primary data from the historical control patients is available and will be used for analysis). Will also compare the nerve cross-sectional area in our study sample to that in the historical diabetic neuropathy patients and historical oxaliplatin neuropathy patients using one-sample t-test. The general linear model will be used to evaluate any factors (e.g., age) that may be associated with the nerve cross-sectional area. Due
Outcome measures
| Measure |
Case
n=20 Participants
Study sample
|
Control
n=120 arm
Historical Control
|
|---|---|---|
|
Tibial Nerve Cross-sectional Area
|
13.0 mm^2
Standard Deviation 3.6
|
14.0 mm^2
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Up to 30 daysSpearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area (tibial cross-sectional area) and nerve conduction studies (amplitude of nerve response - ankle).
Outcome measures
| Measure |
Case
n=20 arm
Study sample
|
Control
Historical Control
|
|---|---|---|
|
Amplitude of Nerve Response - Ankle
|
0.15 Spearman correlation coefficient
|
—
|
SECONDARY outcome
Timeframe: Up to 30 daysSpearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area (tibial cross-sectional area) and nerve conduction studies (conduction velocity of nerve response - tibial).
Outcome measures
| Measure |
Case
n=19 arm
Study sample
|
Control
Historical Control
|
|---|---|---|
|
Conduction Velocity of Nerve Response - Tibial
|
0.15 Spearman correlation coefficient
|
—
|
SECONDARY outcome
Timeframe: Up to 30 daysSpearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area (tibial cross-sectional area) and nerve conduction studies (distal latency of nerve response - ankle).
Outcome measures
| Measure |
Case
n=20 arm
Study sample
|
Control
Historical Control
|
|---|---|---|
|
Distal Latency of Nerve Response - Ankle
|
-0.23 Spearman correlation coefficient
|
—
|
SECONDARY outcome
Timeframe: Up to 30 daysSpearman's rank correlation coefficient will be used to examine the association between nerve cross-sectional area and distal intraepidermal nerve fiber density.
Outcome measures
| Measure |
Case
n=20 arm
Study sample
|
Control
Historical Control
|
|---|---|---|
|
Nerve Fiber Density in the Skin
|
-0.12 Spearman correlation coefficient
|
—
|
SECONDARY outcome
Timeframe: Up to 30 daysWill be assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20. Spearman's rank correlation coefficient will be used to examine the associations between the cross-sectional area and the self-reported neuropathy scale.
Outcome measures
| Measure |
Case
n=20 Participants
Study sample
|
Control
Historical Control
|
|---|---|---|
|
Self-reported Neuropathy Score
|
-0.18 Spearman correlation coefficient
|
—
|
SECONDARY outcome
Timeframe: Up to 30 daysWill be determined by ultrasound of the sural nerve. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies. The general linear model will be also used to evaluate the association after adjusting for one or two risk factors (e.g., age). Nerve cross-sectional area will be treated as the dependent variable.
Outcome measures
| Measure |
Case
n=20 arm
Study sample
|
Control
Historical Control
|
|---|---|---|
|
Sural Nerve Cross-sectional Area
|
0.30 Spearman correlation coefficient
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 30 daysSpearman's rank correlation coefficient will be used to assess the associations between activated mast cells in skin biopsies, serum inflammatory markers, severity of symptoms, and primary outcome and secondary outcomes in taxane-induced peripheral neuropathy patients.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 30 daysSpearman's rank correlation coefficient will be used to assess the associations between activated mast cells in skin biopsies, serum inflammatory markers, severity of symptoms, and primary outcome and secondary outcomes in taxane-induced peripheral neuropathy patients.
Outcome measures
Outcome data not reported
Adverse Events
Case
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Case
n=20 participants at risk
Study sample
|
|---|---|
|
Infections and infestations
Infections and infestations - Other
|
10.0%
2/20 • Number of events 2 • 1 month
Adverse Events were collected during the first treatment cycle. Historical control participants were not a part of this trial and were used as a reference group only. No adverse events were collected from this group.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
10.0%
2/20 • Number of events 2 • 1 month
Adverse Events were collected during the first treatment cycle. Historical control participants were not a part of this trial and were used as a reference group only. No adverse events were collected from this group.
|
Additional Information
Roy Strowd
Wake Forest Baptist Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place