Recruiting

PLCS

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT07064798

Conditions

Chemotherapy-induced Peripheral Neuropathy

Taxane-Induced Peripheral Neuropathy

CIPN - Chemotherapy-Induced Peripheral Neuropathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Paxman Limb Cryocompression System

Study Details

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

Study ID

NCT07064798

Start date

Oct 22, 2025

Status verified date

Nov, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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

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

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). ]
  • Duration of Cryocompression Tolerated During Neurotoxic Chemotherapy [ Time Frame: Up to 12 weeks ]
  • Incidence of Core Temperature Decrease >1°F and Skin Intolerance Symptoms Associated with Cryocompression [ Time Frame: Throughout each chemotherapy infusion visit when cryocompression is applied. Up to 12 weeks ]

Central Contacts and Locations

Central contacts

Theresa Jabaley Leonarczyk, PhD, RN

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

Jabaley Leonarczyk, PhD, RN

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

Locations

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Theresa Leonarczyk, PhD, RN

617-582-8037Theresa_jabaley@dfci.harvard.edu

Theresa Leonarczyk, PhD

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

Principal Investigator:

Theresa Jabaley Leonarczyk, PhD, RN

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Apr 15, 2026

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-04-15.