Actively Recruiting
Exploring the Benefit of Topical Capsaicin in Treating Pain From Chemo-induced Peripheral Neuropathy: a Longitudinal Single Center Pilot Study
Led by M.D. Anderson Cancer Center · Updated on 2026-01-05
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
A
Averitas Pharma, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether a topical capsaicin patch can help relieve pain caused by chemotherapy-induced peripheral neuropathy (CIPN) and improve walking patterns in affected patients. This early phase 1 pilot study aims to assess changes in gait velocity, pain intensity, sensory function, and nerve fiber integrity in patients who have experienced chronic CIPN pain for over 90 days after chemotherapy. Participants will receive up to four topical capsaicin 8% patches applied to their feet for 30 minutes. The study will measure pain intensity using numerical rating scales, evaluate sensory testing results, and optionally perform skin biopsies to assess nerve fiber health before and after treatment. Other assessments include neuropathy pain scales, pain interference questionnaires, and patient impressions of change. The study also monitors safety and adverse events throughout about one year. During the study, participants will undergo repeated assessments of gait, pain, sensory function, and quality of life measures. Researchers will collect data on nerve fiber integrity through optional skin biopsies and track any side effects or tolerability issues related to the topical treatment. The total study duration includes safety follow-up to evaluate adverse events and ensure participant well-being over the course of the trial.
CONDITIONS
Brief Title
Exploring the Benefit of Topical Capsaicin in Treating Pain From Chemo-induced Peripheral Neuropathy: a Longitudinal Single Center Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants diagnosed with pain of the lower extremity from chronic (>90 days duration) chemotherapy-induced peripheral neuropathy due to specific chemotherapy agents
- Participants reporting baseline pain of 4 or higher on a 0-10 scale
- Participants aged 18 years or older
- Participants who have completed chemotherapy within the last year at the time of enrollment
You will not qualify if you...
- Participants with cognitive dysfunction
- Participants with recent history (less than 6 months) of drug or alcohol abuse
- Participants with open skin lesions or undergoing antibiotic therapy for local or systemic infection
- Participants with allergies to capsaicin or adhesives
- Pregnant participants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Through study completion; an average of 1 year
Participants receive up to 4 topical capsaicin patches applied on their feet for 30 minutes to treat pain from chemotherapy-induced peripheral neuropathy.
Multiple visits for patch application and assessments
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Saba Javed, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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