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Evaluating the Use of Limb Cryocompression to Reduce Taxane-induced Peripheral Neuropathy
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)
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Start Date
October 22, 2025
Primary Completion Date
August 1, 2027
Completion Date
August 1, 2027
Last Updated
November 18, 2025
50
ESTIMATED participants
Paxman Limb Cryocompression System
DEVICE
Lead Sponsor
Dana-Farber Cancer Institute
NCT07352514
NCT07164950
Data Source & Attribution
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