High-concentration Capsaicin Patch for the Prevention of Paclitaxel-induced Peripheral Neuropathy

Conditions

• CIPN - Chemotherapy-Induced Peripheral Neuropathy
• Chemotherapy-induced Peripheral Neuropathy

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• High Concentration Capsaicin Patch (HCCP) — OTHER
  Participants will receive 8% HCCP patch. It will be administered on the hand or foot for either 30 or 60 minutes, depending on which arm the participant is in. It will be administered at baseline (Week 0), just prior to starting standard of care chemotherapy. It will be administered again on Week 11, as long as the participant is expected to receive standard of care chemotherapy on Week 12.
• Placebo patch — OTHER
  Participants will receive the placebo patch containing 0.025% capsaicin. It will be administered on the hand or foot for either 30 or 60 minutes, depending on which arm the participant is in. It will be administered at baseline (Week 0), just prior to starting standard of care chemotherapy. It will be administered again on Week 11, as long as the participant is expected to receive standard of care chemotherapy on Week 12.

Study Details

This research study is for participants who are receiving paclitaxel infusion as part of their cancer treatment. The purpose of this study is to test the effectiveness of the Food and Drug Administration (FDA) approved high-concentration (8%) capsaicin patch (HCCP) in prevention of taxane-induced peripheral neuropathy (nerve pain in hands and/or feet). Participants will be randomized, like flipping a coin, into one of four groups. Group one will receive the HCCP on one hand and one foot 60 minutes prior to each infusion. Group two will receive the HCCP on one hand and one foot 30 minutes prior to each infusion. Group three will receive a placebo patch on one hand and one foot containing a very low concentration of capsaicin (0.025%) for 60 minutes prior to infusion. Group four will receive a placebo patch on one hand and one foot for 30 minutes prior to infusion. Participants will have an equal chance of being placed in each of the four groups.

Key Dates

First listed

Sep 22, 2026

Start date

Oct 1, 2026

Status verified

Sep 2026

Primary completion

Jun 30, 2027

Completion

Jun 30, 2028

Study Design

Enrollment

240 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: HCCP 30-minute application
  The 8% High Concentration Capsaicin Patch (HCCP) patch will be administered in an outpatient setting one week prior to the initiation of standard of care chemotherapy. The patch will be administered either on the hand or foot. It will be applied for 30 minutes. If the participant is expected to receive standard of care chemotherapy at Week 12, then they will receive a second HCCP patch on Week 11.
• Experimental: HCCP 60-minute application
  The 8% High Concentration Capsaicin Patch (HCCP) patch will be administered in an outpatient setting one week prior to the initiation of standard of care chemotherapy. The patch will be administered either on the hand or foot. It will be applied for 60 minutes. If the participant is expected to receive standard of care chemotherapy at Week 12, then they will receive a second HCCP patch on Week 11.
• Placebo Comparator: Placebo 30-minute application
  This arm will receive a matched placebo patch containing 0.025% capsaicin. The patch will be administered in an outpatient setting one week prior to the initiation of standard of care chemotherapy. The patch will be administered either on the hand or foot. It will be applied for 30 minutes. If the participant is expected to receive standard of care chemotherapy at Week 12, then they will receive a second HCCP patch on Week 11.
• Placebo Comparator: Placebo 60-minute application
  This arm will receive a matched placebo patch containing 0.025% capsaicin. The patch will be administered in an outpatient setting one week prior to the initiation of standard of care chemotherapy. The patch will be administered either on the hand or foot. It will be applied for 60 minutes. If the participant is expected to receive standard of care chemotherapy at Week 12, then they will receive a second HCCP patch on Week 11.

Primary Outcome Measure

Change in taxane-induced peripheral neuropathy due to HCCP patch [ Time Frame: Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52 ]

Central Contacts

• Jijun Xu, MD, PhD
  (216) 444-4080
  [email protected]
• Heather Rogers
  (216) 444-1292
  [email protected]

Locations (1)

Find similar trials in Cleveland, OH

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