Cryocompression for CIPN

NCT07064798 | Recruiting FDA Device

• 1 other identifier: 25-144
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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)

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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

EXPERIMENTAL

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

Arm B: Standard of Care Taxane-based Chemotherapy

NO INTERVENTION

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

Interventions

Paxman Limb Cryocompression System 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

Also known as: PLCS

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Theresa Jabaley Leonarczyk, PhD, RN

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

• Leonarczyk

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Theresa Jabaley Leonarczyk, PhD, RN

CONTACT

617-582-8037; theresa_jabaley@dfci.harvard.edu

Jabaley Leonarczyk, PhD, RN

CONTACT

617-582-8037; theresa_jabaley@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 15, 2025
• Study Start: October 22, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (1)