Evaluating the Paxman Limb Cryocompression System to Prevent Nerve Damage in Cancer Patients Receiving Chemotherapy

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a new limb cryocompression device called the Paxman Limb Cryocompression System PLCS in preventing chemotherapy-induced peripheral neuropathy in cancer patients. This study involves 200 cancer patients receiving weekly paclitaxel chemotherapy, aiming to develop a therapy that reduces nerve damage caused by chemotherapy. The trial is sponsored by the National University Hospital, Singapore, and includes participants aged 21 to 80 years. Participants will undergo limb cryocompression treatment during each chemotherapy cycle using cooling wraps that cover the limbs from the digits to the elbow or knee. The therapy involves 30 minutes of cooling before chemotherapy infusion, continued cooling during chemotherapy, and 30 minutes after infusion, totaling up to 4 hours per cycle. This cryocompression treatment is repeated for up to 12 cycles, with the possibility of extension after consultation with the principal investigator. Throughout the study, participants will be monitored for treatment-emergent adverse events using established criteria over a 4-month period and assessed for changes in neuropathy symptoms using a quality-of-life questionnaire over 16 months. Usability of the PLCS device will also be evaluated. Monitoring will include repeated safety and symptom assessments during and after cryocompression treatment, with the total study duration extending up to 16 months.

A Novel Limb Cryocompression System for Prevention of Chemotherapy Induced Peripheral Neuropathy - Expansion Study