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

Early Phase 1

Not yet recruiting

• Conditions: Peripheral Neuropathy Due to Chemotherapy
• Interventions: Drug: Qutenza Patch

• Registration Number: NCT06744816
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-19
• Study First Posted: 2024-12-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31
• Study Start: 2025-06-05
• Primary Completion: 2025-11-30
• Study Completion: 2027-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with Qutenza Patch (Topical Capsaicin)	Qutenza Patch	Up to 4 topical capsaicin patches will be applied on your feet for 30 minutes.

Primary Outcome Measures

Name	Time	Method
Safety and adverse events (AE)s	Through study completion; an average of 1 year	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States