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

ConditionPeripheral Neuropathy Due to Chemotherapy

Trial statusRecruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorM.D. Anderson Cancer Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

Qutenza Patch
Drug
Given topical

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: Treatment with Qutenza Patch (Topical Capsaicin)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

Through study completion; an average of 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Averitas Pharma, Inc.

Collaborator

Source ClinicalTrials.gov

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