Exploring the Benefit of Topical Capsaicin in Treating Pain From Chemo-induced Peripheral Neuropathy: a Longitudinal Single Center Pilot Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Qutenza Patch.
- Who it may be relevant to
- Registry conditions: Peripheral Neuropathy Due to Chemotherapy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
To learn if topical capsaicin can help relieve pain from CIPN and improve gait (the pattern of walking) in patients.
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
Interventions
- Drug Qutenza Patch
Given topical
Primary outcome measures
- Safety and adverse events (AE)s [Time frame: Through study completion; an average of 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- MD Anderson Cancer Center — Houston
Identifiers
NCT: NCT06744816 · 2024-1601 · NCI-2024-10413