Cryocompression for CIPN

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)

Study Overview

• Status: Recruiting
• Conditions: Chemotherapy-induced Peripheral Neuropathy; CIPN - Chemotherapy-Induced Peripheral Neuropathy; Taxane-Induced Peripheral Neuropathy
• Intervention / Treatment: Device: Paxman Limb Cryocompression System

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Theresa Jabaley Leonarczyk, PhD, RN; Phone Number: 617-582-8037; Email: theresa_jabaley@dfci.harvard.edu
• Study Contact Backup: Name: Jabaley Leonarczyk, PhD, RN; Phone Number: 617-582-8037; Email: theresa_jabaley@dfci.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
      • Principal Investigator: Theresa Jabaley Leonarczyk, PhD, RN
      • Contact: Theresa Leonarczyk, PhD, RN; Phone Number: 617-582-8037; Email: Theresa_jabaley@dfci.harvard.edu
      • Contact: Theresa Leonarczyk, PhD; Phone Number: 617-582-8037; Email: theresa_jabaley@dfci.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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, Q2 weeks paclitaxel X4 (preceded by doxorubicin/cyclophosphamide). (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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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; Other Names: PLCS
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient-Reported CIPN Symptoms Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy module at End of Treatment	Chemotherapy-induced peripheral neuropathy (CIPN) will be assessed using the validated European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy module (EORTC QLQ-CIPN20). This aim is defined as evaluating the incidence and severity of subjectively reported CIPN symptoms, including numbness, tingling, and pain in hands and feet. Clinically significant CIPN is expected to emerge during taxane-based treatment and will be captured at the follow-up visit post-treatment.	Assessed 1-4 weeks after the final taxane infusion (end of treatment).
Duration of Cryocompression Tolerated During Neurotoxic Chemotherapy	Tolerance of cryocompression will be defined by the total amount of time (in minutes) the participant is able to wear cryocompression devices during chemotherapy infusions. This aim evaluates feasibility and tolerability from the patient perspective, based on self-reported ability to continue cryocompression throughout the infusion. Early removal or shortened wear time due to discomfort will be recorded.	Up to 12 weeks
Incidence of Core Temperature Decrease >1°F and Skin Intolerance Symptoms Associated with Cryocompression	This aim assesses the physiological safety of cryocompression. Core body temperature will be monitored orally before, during, and after cryocompression application, with any decreases greater than 1°F considered significant. Skin will be evaluated for intolerance signs (e.g., white or greyish-yellow discoloration, pain, tingling, numbness, or pressure) on cryocompressed limbs. The aim is defined as the absence of these adverse effects during cryocompression use.	Throughout each chemotherapy infusion visit when cryocompression is applied. Up to 12 weeks

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: Paxman Coolers Limited
• Investigators: Principal Investigator: Theresa Jabaley Leonarczyk, PhD, RN, Dana-Farber Cancer Institute; Principal Investigator: Leonarczyk, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: July 7, 2025
• First Submitted That Met QC Criteria: July 7, 2025
• First Posted (Actual): July 15, 2025

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: CIPN; Peripheral Neuropathy; Chemotherapy-induced Peripheral Neuropathy; Taxane-Induced Peripheral Neuropathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: 25-144

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes