Trial Outcomes & Findings for Topical Menthol for the Treatment of Chemotherapy Induced Peripheral Neuropathy (NCT NCT01855607)
NCT ID: NCT01855607
Last Updated: 2024-07-11
Results Overview
The Brief Pain Inventory-Short Form (BPI-SF) is a well-validated clinical tool used frequently to assess severity of pain and its effect on daily functions in patients with neuropathy. The instrument gives several ratings of the intensity and severity of pain and the degree of pain interference on activity, mood, sleep, relations with others and work. The questionnaire uses a 0-10 scale with a higher score indicating a worse outcome.
TERMINATED
PHASE2
12 participants
Baseline and 6 weeks
2024-07-11
Participant Flow
The study was terminated before randomization could be assigned, therefore all participant data is presented as a combined total and cannot be presented per Arm.
Participant milestones
| Measure |
All Participants
Patients with neuropathic pain will receive topical menthol or placebo lotion following or during chemotherapy for the treatment of either breast, gastrointestinal, or gynecologic cancer.
Topical menthol: 7.5% Methylsalicylate and 2% Menthol Lotion
Placebo lotion: 7.5% Methylsalicylate and no menthol.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
All Participants
Patients with neuropathic pain will receive topical menthol or placebo lotion following or during chemotherapy for the treatment of either breast, gastrointestinal, or gynecologic cancer.
Topical menthol: 7.5% Methylsalicylate and 2% Menthol Lotion
Placebo lotion: 7.5% Methylsalicylate and no menthol.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Study was terminated
|
11
|
Baseline Characteristics
Topical Menthol for the Treatment of Chemotherapy Induced Peripheral Neuropathy
Baseline characteristics by cohort
| Measure |
All Participants
n=11 Participants
Patients with neuropathic pain will receive topical menthol or placebo lotion following or during chemotherapy for the treatment of either breast, gastrointestinal, or gynecologic cancer.
Topical menthol: 7.5% Methylsalicylate and 2% Menthol Lotion
Placebo lotion: 7.5% Methylsalicylate and no menthol.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 weeksPopulation: The study was terminated due to poor enrollment; no data was collected from participants. Participants were not randomized, therefore results are reported as a combined total and cannot be presented per Arm.
The Brief Pain Inventory-Short Form (BPI-SF) is a well-validated clinical tool used frequently to assess severity of pain and its effect on daily functions in patients with neuropathy. The instrument gives several ratings of the intensity and severity of pain and the degree of pain interference on activity, mood, sleep, relations with others and work. The questionnaire uses a 0-10 scale with a higher score indicating a worse outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: The study was terminated due to poor enrollment; no data was collected from participants. Participants were not randomized, therefore results are reported as a combined total and cannot be presented per Arm.
The European Organization for Research and Treatment of Cancer Chemotherapy-induced peripheral neuropathy (EORTC-CIPN20) is a questionnaire measuring patient reported symptoms of chemotherapy induced neuropathy. Scores range from 20-80 with a higher score indicating a worse outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: The study was terminated due to poor enrollment; no data was collected from participants. Participants were not randomized, therefore results are reported as a combined total and cannot be presented per Arm.
Sensorimotor function as measured by a Bio-Thesiometer, which measures changes in vibratory perception. The Bio-Thesiometer is an electrical tuning fork whose amplitude can be gradually increased. Vibration threshold will be assessed at the dorsum of the distal interphalangeal joint of the index finger and dorsum of the interphalangeal joint of the hallux. Subjects will be asked to indicate when the vibration stimulus is initially felt (perception threshold) and when the stimulus disappears (disappearance threshold.) The vibration perception threshold is the average of three paired measurements.
Outcome measures
Outcome data not reported
Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dawn L. Hershman, MD, MS, FASCO
Columbia University Irving Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place