Study of Paxman Limb Cryocompression System to Reduce Peripheral Neuropathy During Taxane Chemotherapy for Breast and Gynecologic Cancer

What this Trial Is About

Researchers are evaluating the use of cooling therapy combined with pressure, known as cryocompression, to reduce peripheral neuropathy caused by taxane-based chemotherapy. This condition affects the nerves in the arms and legs, potentially causing numbness, pain, or loss of motor function. The study aims to assess the effectiveness, tolerability, and safety of the Paxman Limb Cryocompression System, a device designed to provide controlled cooling and compression during chemotherapy. Participants will be randomly assigned to one of two groups one group will receive cryocompression along with their standard taxane-based chemotherapy, while the other will receive only the standard chemotherapy. The study uses a 21 randomization ratio, giving participants about twice the chance of being in the cryocompression group. Study visits include baseline assessments, chemotherapy treatments with or without cryocompression, and an end-of-treatment visit. During the study, participants will complete questionnaires and attend clinic visits to monitor their condition. Researchers will measure changes in patient-reported neuropathy symptoms using a quality of life questionnaire after treatment, monitor how long participants tolerate the cryocompression during chemotherapy up to 12 weeks, and track any core temperature drops or skin issues related to the therapy. The study expects to enroll about 50 people and will continue until August 2027.

Cryocompression for CIPN