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A Novel Limb Cryocompression System for Prevention of Chemotherapy Induced Peripheral Neuropathy
Sponsor: National University Hospital, Singapore
Summary
The study aims to investigate the safety and tolerability of limb cryocompression in preventing of Chemotherapy-induced Peripheral Neuropathy via a newly developed limb cryocompression device in healthy subjects and cancer patients. The limb cryocompression device will be tested for its safety in delivering limb cryocompression and efficacy in improving the preservation of peripheral nerves during chemotherapy.
Key Details
Gender
All
Age Range
21 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2021-11-03
Completion Date
2023-07-05
Last Updated
2026-06-22
Healthy Volunteers
Yes
Interventions
Paxman Cryocompression System (PCCS)
Establishing optimal temperature and pressure for limb cryocompression therapy. Healthy subjects will undergo 3 hours of limb cryocompression. The cryocompression device used in this study consists of a control unit, and limb wraps. The control unit contains the coolant reservoir and pump to circulate the coolant and air for compression. It is able to thermoregulate (control the temperature of the circulating coolant) and offer cyclic air pressure in the wraps. The wraps cover the limbs from the elbow/knee to the fingers/toes.
Paxman Cryocompression System (PCCS)
The study population will comprise of cancer patients scheduled to receive weekly paclitaxel chemotherapy for a maximum of 12 cycles. Paclitaxel will be administered as a one-hour infusion. Limb cryocompression sessions comprised of a pre-cooling period (up to one hour), continued with paclitaxel infusion and a post-cooling period (on average 30 minutes after the end of paclitaxel infusion). Overall, limb cryocompression will be administered for no longer than four hours.
Locations (1)
National University Hospital
Singapore, Singapore