Use of Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer a Randomized Controlled Trial - COHORT 2

What this Trial Is About

Researchers are evaluating the effect of cryotherapy wraps combined with compression therapy cryocompression compared to cryotherapy wraps alone on the incidence and severity of chemotherapy-induced peripheral neuropathy in patients with gynecologic cancer. This study uses a noninferiority design to see if cryotherapy alone is not worse than cryocompression. The study also aims to assess patient tolerability and satisfaction, as well as staff satisfaction with these treatments during chemotherapy. Participants will be randomly assigned to receive either cryotherapy wraps plus compression therapy or cryotherapy wraps alone on both hands and feet. These treatments will be applied during each taxane chemotherapy infusion, which typically occurs every three weeks over at least six cycles. Both groups will undergo their assigned therapy for the duration of their taxane infusions. During the study, participants will complete surveys at each infusion visit to report symptoms related to neuropathy using FACT-NTX and Patient Neurotoxicity Questionnaires PNQ. They will also complete brief surveys on treatment acceptability and tolerability, while staff involved in care will complete satisfaction surveys. Researchers will monitor for adverse events such as frostbite, unexpected hospitalizations, and death. The primary outcome measured is the change over time in neuropathy symptoms reported by patients, tracked up to two months after chemotherapy, with an average follow-up of six months.

Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer - COHORT 2