NCT06744816

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
19mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Dec 2025Nov 2027

First Submitted

Initial submission to the registry

December 17, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2024

Completed
12 months until next milestone

Study Start

First participant enrolled

December 11, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

2 years

First QC Date

December 17, 2024

Last Update Submit

December 30, 2025

Conditions

Peripheral Neuropathy Due to Chemotherapy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Treatment with Qutenza Patch (Topical Capsaicin)

EXPERIMENTAL

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

Drug: Qutenza Patch

Interventions

Qutenza PatchDRUG

Given topical

Treatment with Qutenza Patch (Topical Capsaicin)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

Study Officials

  • Saba Javed, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Saba Javed, MD

CONTACT

713-792-9530sjaved@mdanderson.org

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2024

First Posted

December 20, 2024

Study Start

December 11, 2025

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2027

Last Updated

January 5, 2026

Record last verified: 2025-12

Locations

US(1)