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NCT Number: NCT06744816

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Saba Javed, MD

CONTACT

[email protected]

713-792-9530

Saba Javed, MD

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Qutenza Patch

Drug

Given topical

Primary outcomes

  1. Safety and adverse events (AE)s

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Saba Javed, MD

CONTACT

[email protected]

713-792-9530

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • Averitas Pharma, Inc.

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 20, 2024
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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