Actively Recruiting
Evaluating the Use of Limb Cryocompression to Reduce Taxane-induced Peripheral Neuropathy
Led by Dana-Farber Cancer Institute · Updated on 2026-04-15
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of cooling therapy combined with pressure, known as cryocompression, to reduce peripheral neuropathy caused by taxane-based chemotherapy. This condition affects the nerves in the arms and legs, potentially causing numbness, pain, or loss of motor function. The study aims to assess the effectiveness, tolerability, and safety of the Paxman Limb Cryocompression System, a device designed to provide controlled cooling and compression during chemotherapy. Participants will be randomly assigned to one of two groups: one group will receive cryocompression along with their standard taxane-based chemotherapy, while the other will receive only the standard chemotherapy. The study uses a 2:1 randomization ratio, giving participants about twice the chance of being in the cryocompression group. Study visits include baseline assessments, chemotherapy treatments with or without cryocompression, and an end-of-treatment visit. During the study, participants will complete questionnaires and attend clinic visits to monitor their condition. Researchers will measure changes in patient-reported neuropathy symptoms using a quality of life questionnaire after treatment, monitor how long participants tolerate the cryocompression during chemotherapy (up to 12 weeks), and track any core temperature drops or skin issues related to the therapy. The study expects to enroll about 50 people and will continue until August 2027.
CONDITIONS
Brief Title
Cryocompression for CIPN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults > 18 years of age
- Diagnosis of gynecologic or breast malignancy
- Starting first cycle of specified taxane-based chemotherapy regimens
- Receiving treatment at the main campus of Dana-Farber Cancer Institute
- Able to complete questionnaires in English or Spanish
You will not qualify if you...
- 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 therapy
- Lymphedema in limbs where device would be applied
- Open skin wounds or ulcers on limbs where device would be applied
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive taxane-based chemotherapy with or without the Paxman Limb Cryocompression System applied during chemotherapy visits to reduce peripheral neuropathy symptoms.
Standard of care chemotherapy visits with cryocompression for Arm A or without cryocompression for Arm B
Duration - 1 to 4 weeks
Participants complete questionnaires to assess peripheral neuropathy symptoms 1 to 4 weeks after the final chemotherapy infusion.
1 end of treatment visit
Trial Site Locations
Total: 1 location
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
T
Theresa Jabaley Leonarczyk, PhD, RN
J
Jabaley Leonarczyk, PhD, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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