Peripheral Neuropathy Due to Chemotherapy
Conditions
Brief summary
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
DRUGQutenza Patch
Given topical
Sponsors
M.D. Anderson Cancer Center
Averitas Pharma, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and adverse events (AE)s | 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 |
Countries
United States
Contacts
CONTACTSaba Javed, MD
PRINCIPAL_INVESTIGATORSaba Javed, MD
M.D. Anderson Cancer Center
Outcome results
None listed