Cryocompression for CIPN

NCT ID: NCT07064798

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-22
• Study Completion Date: 2027-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

Paxman Limb Cryocompression System

Intervention Type: DEVICE

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

Arm B: Standard of Care Taxane-based Chemotherapy

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

PLCS

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Theresa Jabaley, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Theresa Jabaley Leonarczyk, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Leonarczyk

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Theresa Jabaley Leonarczyk, PhD, RN

Role: CONTACT

theresa_jabaley@dfci.harvard.edu

617-582-8037

Jabaley Leonarczyk, PhD, RN

Role: CONTACT

theresa_jabaley@dfci.harvard.edu

617-582-8037

Facility Contacts

Theresa Leonarczyk, PhD, RN

Role: primary

Theresa_jabaley@dfci.harvard.edu

617-582-8037

Theresa Leonarczyk, PhD

Role: backup

theresa_jabaley@dfci.harvard.edu

617-582-8037

Other Identifiers

25-144

Identifier Type: -

Identifier Source: org_study_id