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

M.D. Anderson Cancer Center

Status and phase: Begins enrollment this month; Early Phase 1

Conditions: Peripheral Neuropathy Due to Chemotherapy

Treatments: Drug: Qutenza Patch

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06744816

2024-1601

NCI-2024-10413 (Other Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Treatment with Qutenza Patch (Topical Capsaicin)

Experimental group

Description:

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

Treatment:

Drug: Qutenza Patch

Sponsors of this trial

Lead Sponsor

M.D. Anderson Cancer Center

Collaborating Sponsor

Averitas Pharma