Cryocompression for CIPN

Dana-Farber Cancer Institute

Status: Enrolling

Conditions: Chemotherapy-induced Peripheral Neuropathy; CIPN - Chemotherapy-Induced Peripheral Neuropathy; Taxane-Induced Peripheral Neuropathy

Treatments: Device: Paxman Limb Cryocompression System

Study type: Interventional

Funder types: Other

Identifiers

NCT07064798

25-144

Details and patient eligibility

About

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)

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults > 18 years of age

• Gynecologic or breast malignancy

• Starting 1st cycle of treatment with chemotherapy regimens:

  • Weekly paclitaxel x 12 or weekly paclitaxel/carboplatin x 12 (Breast Oncology)
  • Q3 weeks paclitaxel/carboplatin X 6-8 (GYN)

• Receiving treatment on the main campus of DFCI (these patients are currently seen on Yawkey 9 and 10 and at Chestnut Hill)

• Able to complete questionnaires in English or Spanish

Exclusion criteria

• Previous exposure to neurotoxic chemotherapy
• Pre-existing neuropathy
• History of Raynaud's phenomenon, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, post-traumatic cold dystrophy, peripheral arterial ischemia, or sickle cell disease
• Undergoing desensitization
• Lymphedema in the limb where the device would be applied
• Open skin wounds or ulcers of the limbs where the device would be applied

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Arm A: Cryocompression + Standard of Care Taxane-Based Chemotherapy

Experimental group

Description:

Participants will be randomized and stratified by chemotherapy regimen and will complete: * Baseline visit with questionnaires * Standard of care chemotherapy visits with cryocompression * End of treatment visit

Treatment:

Device: Paxman Limb Cryocompression System

Arm B: Standard of Care Taxane-based Chemotherapy

No Intervention group

Description:

Participants will be randomized and stratified by chemotherapy regimen and will complete: * Baseline visit with questionnaires * Standard of care chemotherapy visits * End of treatment visit