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

NCT07834281 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: CASE10Z26
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy; CIPN - Chemotherapy-Induced Peripheral Neuropathy

Keywords

high-concentration capsaicin patch; HCCP

Outcome Measures

Primary Outcomes (1)

• Change in taxane-induced peripheral neuropathy due to HCCP patch

  Change in taxane-induced peripheral neuropathy is measured by the incidence of grade ≥2 neuropathy (Common Terminology Criteria for Adverse Events, CTCAE v5.0).

  Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52

Secondary Outcomes (11)

• Change in FACT-GOG-Ntx scores

  Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52

• Change in PROMIS Pain Interference scores

  Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52

• Change in PROMIS Physical Function scores

  Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52

• Change in PROMIS Sleep Disturbance scores

  Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52

• Change in EQ-5D-5L scores

  Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52

Study Arms (4)

HCCP 30-minute application

EXPERIMENTAL

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.

Other: High Concentration Capsaicin Patch (HCCP)

HCCP 60-minute application

EXPERIMENTAL

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.

Other: High Concentration Capsaicin Patch (HCCP)

Placebo 30-minute application

PLACEBO COMPARATOR

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.

Other: Placebo patch

Placebo 60-minute application

PLACEBO COMPARATOR

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.

Other: Placebo patch

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.

HCCP 30-minute application; HCCP 60-minute application

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.

Placebo 30-minute application; Placebo 60-minute application

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult participants (ages 18-65 years old)
• Eligible participants must have intact skin in the areas to be treated (hands and feet)
• Participants must have the ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Participants with pre-existing peripheral neuropathy, concurrent use of other neurotoxic medications, palliative-intent chemotherapy, pregnancy, inability to provide informed consent or participate in follow-up visits, or any contraindications listed in the HCCP Summary of Product Characteristics (SmPC)8 will be excluded.
• Pregnant or breastfeeding women are excluded from this study because Paclitaxel is a chemotherapy agent with the potential for teratogenic or abortifacient effects.
• HIV-positive participants will not be excluded unless the participant has an established peripheral neuropathy related to HIV or its treatment. HIV testing is not required for this study.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

Study Officials

• Jijun Xu, MD, PhD

  Case Comprehensive Cancer Center, Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jijun Xu, MD, PhD

CONTACT

(216) 444-4080; Xuj3@ccf.org

Heather Rogers

CONTACT

(216) 444-1292; ROGERSH3@ccf.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 22, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)