Case Comprehensive Cancer Center
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.
Chemotherapy-induced peripheral neuropathy (CIPN) is a common, serious side effect of drugs used to treat cancer, such as taxanes. CIPN affects up to 80% of people receiving chemotherapy cancer treatment, and the incidence of CIPN is expected to increase as cancer survival increases. CIPN can cause sensory loss, neuropathic (nerve-related) pain, gait instability (problems with balance), and fine motor impairment. These symptoms can often continue for years after treatment is completed. These symptoms may also cause doctors to lower or stop chemotherapy, which may affect the outcomes of cancer…
Inclusion Criteria: * 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. Exclusion Criteria: * 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…
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.
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.
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