NCT07064798

Cryocompression for CIPN

Evaluating the Use of Limb Cryocompression to Reduce Taxane-induced Peripheral Neuropathy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the effectiveness, tolerability, and safety of using cooling therapy and pressure (cryocompression) to reduce peripheral neuropathy, a condition affecting the nerves supplying the arms and legs (limbs) resulting in possible numbness, pain, and/or loss of motor function, that may occur as a result of taxane-based chemotherapy. The name of the device used in this research study is: -Paxman Limb Cryocompression System (PLCS)

Detailed description

This randomized controlled trial aims to evaluate the effectiveness, tolerability, and safety of using cooling therapy and pressure (cryocompression) to reduce peripheral neuropathy, a condition affecting the nerves supplying the arms and legs (limbs) resulting in possible numbness, pain, and/or loss of motor function, that may occur as a result of taxane-based chemotherapy. There is evidence that cooling therapy may be effective for preventing peripheral neuropathy caused by taxane-based chemotherapy. The U.S. Food and Drug Administration (FDA) has not approved the PAXMAN Limb Cryocompression System as a treatment to reduce peripheral neuropathy. Participants will be randomized into 1 of 2 groups: Arm A: Cryocompression + Standard of Care Taxane-Based Chemotherapy versus Arm B: Standard of Care Taxane-Based Chemotherapy. Participants will be randomized in a 2:1 manner, meaning a participant is 2 times the chance (approximately 67%) of being in Arm A than in Arm B (approximately 33%). Randomization means a participant is placed into a study group by chance. The research study procedures include screening for eligibility, in-clinic visits, and questionnaires. It is expected that about 50 people will take part in this research study. Paxman Coolers, Inc. is providing the Paxman Limb Cryocompression Systems for this study.

Conditions

• Chemotherapy-induced Peripheral Neuropathy
• Taxane-Induced Peripheral Neuropathy
• CIPN - Chemotherapy-Induced Peripheral Neuropathy

Interventions

Type	Name	Description
DEVICE	Paxman Limb Cryocompression System	An investigational device designed to provide controlled cooling and compression to participant limbs during chemotherapy administration. The device is comprised of a control unit, connecting hose, and two limb wraps. The customizable limb wraps delivers continuous-flow cooling-and-compression to participant extremities

Timeline

• Start date: 2025-10-22
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2025-07-15
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study