Phase 3 Study Comparing Three Limb Cooling and Compression Methods to Prevent Nerve Damage from Taxane Chemotherapy

What this Trial Is About

Researchers are assessing three different methods to prevent peripheral neuropathy caused by taxane chemotherapy drugs like paclitaxel or docetaxel. This phase III trial compares cryocompression, continuous compression, and low cyclic compression therapies using the Paxman Limb Cryocompression System, which applies cooling andor pressure to the arms and legs. The study aims to see if any of these approaches can reduce the nerve damage that leads to numbness, tingling, or pain during chemotherapy. Participants are randomly assigned to one of three groups cryocompression therapy cooling plus moderate and low pressure, continuous compression therapy steady moderate pressure, or low cyclic compression therapy low pressure that cycles on and off. Each therapy is applied for 30 minutes before, during, and after each taxane chemotherapy infusion. Blood, serum, and plasma samples may be collected during screening and throughout the study. During the study, participants will complete questionnaires and undergo evaluations of nerve function and physical tests at multiple time points up to 52 weeks. Researchers will monitor side effects related to the devices, participant satisfaction, and chemotherapy dosing impacts. The main outcome measured is the occurrence of clinically meaningful chemotherapy-induced peripheral neuropathy at 12 weeks after starting treatment, with additional assessments over time to understand the therapies effects and tolerability.

Comparing Cooling and/or Compression Approaches of Limbs for Prevention of Chemotherapy-Induced Peripheral Neuropathy