RecruitingNot ApplicableNCT07064798

Cryocompression for CIPN

Evaluating the Use of Limb Cryocompression to Reduce Taxane-induced Peripheral Neuropathy


Sponsor

Dana-Farber Cancer Institute

Enrollment

50 participants

Start Date

Oct 22, 2025

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria6

  • 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

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Interventions

DEVICEPaxman 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


Locations(1)

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

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NCT07064798


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