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

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

Study Overview

• Status: Recruiting
• Conditions: Peripheral Neuropathy Due to Chemotherapy
• Intervention / Treatment: Drug: Qutenza Patch

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Saba Javed, MD; Phone Number: 713-792-9530; Email: sjaved@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center
      • Contact: Saba Javed, MD; Phone Number: 713-792-9530; Email: sjaved@mdanderson.org
      • Principal Investigator: Saba Javed, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with Qutenza Patch (Topical Capsaicin); Up to 4 topical capsaicin patches will be applied on your feet for 30 minutes.	Drug: Qutenza Patch; Given topical

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: Averitas Pharma, Inc.
• Investigators: Principal Investigator: Saba Javed, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): December 20, 2024

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Physiological Effects of Drugs; Peripheral Nervous System Agents; Dermatologic Agents; Sensory System Agents; Antipruritics; Capsaicin
• Other Study ID Numbers: 2024-1601; NCI-2024-10413 (Other Identifier: NCI-CTRP Clinical Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No