NCT05095051

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study consists of two parts. The first part of the study will consist of up to 18 healthy subjects to assess safety and tolerability of the new limb cryocompression device. The occurrence or lack of core hypothermia will be studied. The second part of the study will consist of 15 cancer patients recruited from the National University Hospital. Patients will undergo cryocompression over multiple cycles of chemotherapy to establish safety and tolerability of repeated therapy. Cryocompression of the limbs will be administered using cooling wraps attached to a cooling device. The limbs will be cooled from the digits to the elbow/knee.

Conditions

• Chemotherapy-induced Peripheral Neuropathy

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2021-11-03
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2021-10-27
• Last updated: 2021-11-12

Locations

1 site across 1 country: Singapore