Topical capsaicin for pain and walking problems from chemotherapy-related peripheral neuropathy
Exploring the Benefit of Topical Capsaicin in Treating Pain From Chemo-induced Peripheral Neuropathy: a Longitudinal Single Center Pilot Study
This will try an 8% capsaicin patch on adults with chemotherapy-related peripheral neuropathy to see if it lowers pain and improves walking.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06744816 on ClinicalTrials.gov |
What this trial studies
This is a single-center, early-phase pilot that applies an 8% topical capsaicin (Qutenza) patch to adult patients with chronic lower-extremity chemotherapy-induced peripheral neuropathy. The primary measure is change in gait velocity before and after the patch; secondary measures include pain numerical rating scale, quantitative sensory testing, optional skin punch biopsy for nerve fibers and Meissner's corpuscles, BPI pain interference, PGIC, and safety/tolerability. Participants must have had ongoing CIPN for at least 90 days, a baseline pain score ≥4, and completed chemotherapy within the past year. Safety events and tolerability are recorded throughout follow-up visits at MD Anderson Cancer Center.
Who should consider this trial
Good fit: Ideal candidates are adults (18+) with chronic lower-extremity chemotherapy-induced peripheral neuropathy of at least 90 days' duration, a baseline pain score of 4 or greater, who completed chemotherapy within the last year and can attend MD Anderson visits.
Not a fit: Patients who are pregnant, allergic to capsaicin or adhesives, have open skin lesions or active infection at the application site, significant cognitive dysfunction, or recent (within 6 months) drug or alcohol abuse are excluded and would not be expected to receive benefit from this intervention.
Why it matters
Potential benefit: If successful, the patch could provide localized, non-systemic pain relief and improve walking speed and daily function for people with chemo-induced peripheral neuropathy.
How similar studies have performed: High-concentration capsaicin patches (Qutenza) have produced pain relief in other forms of peripheral neuropathic pain such as postherpetic neuralgia, but evidence specifically for chemotherapy-induced peripheral neuropathy is limited and primarily from small or early-phase reports.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants diagnosed with pain of the lower extremity from chronic (\>90 days duration) CIPN (due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds), seen at MD Anderson Cancer Center * Participants reporting baseline pain ≥ 4 (0-10 scale, NRS) * Participants age 18+ * Participants who have completed chemotherapy within the last year at the time of enrollment. Exclusion Criteria: * Participants with cognitive dysfunction * Participants with recent history (\<6 months) of drug or alcohol abuse * Participants with open skin lesion or undergoing antibiotic therapy for local for systemic infection * Participants with allergies to capsaicin or adhesives * Pregnant participants
Where this trial is running
Houston, Texas
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Saba Javed, MD — M.D. Anderson Cancer Center
- Study coordinator: Saba Javed, MD
- Email: sjaved@mdanderson.org
- Phone: 713-792-9530
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.