Exploring the Benefit of Topical Capsaicin in Treating Pain From Chemo-induced Peripheral Neuropathy: a Longitudinal Single Center Pilot Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-11

Study Completion Date

2027-11-30

Brief Summary

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To learn if topical capsaicin can help relieve pain from CIPN and improve gait (the pattern of walking) in patients.

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Detailed Description

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Primary Objectives

• To assess changes in Gait (specifically looking at velocity) before and after use of topical capsaicin.

Secondary Objectives

* To assess Pain intensity numerical rating scale (NRS) scores in chemotherapy induced peripheral neuropathy (CIPN) participants before and after use of capsaicin 8% topical patch.
* To assess changes in quantitative sensory testing (QST) before and after use of topical capsaicin.
* To assess skin punch biopsy to compare the integrity of epidermal nerve fibers and Meissner's corpuscles (MC) in CIPN patients before and after use of topical capsaicin (optional).
* To assess pain tumor related neuropathy assessment scale (TNAS) before and after topical capsaicin
* To assess pain interference using the Brief Pain Inventory (BPI), before and after topical capsaicin
* To assess Patient Global Impression of Change (PGIC)
* To assess the rate of adverse events and tolerability of topical capsaicin as reported by participants

Conditions

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Peripheral Neuropathy Due to Chemotherapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment with Qutenza Patch (Topical Capsaicin)

Up to 4 topical capsaicin patches will be applied on your feet for 30 minutes.

Group Type EXPERIMENTAL

Qutenza Patch

Intervention Type DRUG

Given topical

Interventions

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Qutenza Patch

Given topical

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No