Cryocompression for CIPN

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT07064798
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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)

Key Dates

Start date
Oct 22, 2025
Status verified
Nov 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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
  • 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

Primary Outcome Measure

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 [ Time Frame: Assessed 1-4 weeks after the final taxane infusion (end of treatment). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215
Theresa Leonarczyk, PhD, RN
[email protected]
617-582-8037
Theresa Leonarczyk, PhD
[email protected]
617-582-8037
Theresa Jabaley Leonarczyk, PhD, RN (PRINCIPAL_INVESTIGATOR)

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By research site
Dana-Farber Cancer Institute· Boston, MA

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