Abstract
124 Background: Chemotherapy induced peripheral neuropathy (CIPN) is a common and potentially debilitating side effect of taxanes. Prior studies indicate weekly paclitaxel results in grade 2 or higher neuropathy in 25% of patients. Patients may experience persistent pain that impacts quality of life. Currently, there is little data that exists on effective therapies for prevention of paclitaxel neuropathy. This study investigates the efficacy and safety of cryotherapy for the prevention of paclitaxel-induced peripheral neuropathy. Methods: This is a single arm, phase II study of the effects of cryotherapy for breast cancer patients undergoing 12 cycles of weekly paclitaxel. Cryotherapy was administered by hypothermia mitts and slippers to patients’ hands and feet during, and 15 minutes before and after paclitaxel treatments. Neurologic assessments and neuropathy questionnaires were evaluated at baseline, every 4 cycles during treatment, and every 6 months follow up for two years. The primary objective is to assess if cryotherapy can decrease the rate of peripheral neuropathy. The primary efficacy endpoint is the rate of neuropathy in patients undergoing weekly paclitaxel treatments. Results: Between November 2014 and June 2015, 41 patients were enrolled in the study. Of 39 evaluable patients, 19 (48.7%) were without neurologic toxicity. 19 (48.7%) had grade 1 toxicity, paresthesia but without pain. Only one patient (2.6%) had grade 2 toxicity. Cryotherapy treatment was well tolerated; one patient could not participate due to cold intolerance. Conclusions: Cryotherapy reduced the incidence of pain and grade 2 or higher sensory neuropathy in patients receiving weekly paclitaxel. Clinical trial information: NCT02230319. [Table: see text]
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