Cryocompression to prevent taxane-induced nerve damage in the arms and legs.
Evaluating the Use of Limb Cryocompression to Reduce Taxane-induced Peripheral Neuropathy
This study tests whether cooling and pressure applied to the arms and legs during taxane chemotherapy can prevent or reduce numbness, pain, or weakness from peripheral neuropathy in adults with breast or gynecologic cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide, doxorubicin |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07064798 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will enroll about 50 adults with breast or gynecologic cancer starting taxane-based chemotherapy and randomize them 2:1 to receive limb cryocompression with the Paxman device plus standard chemotherapy versus standard chemotherapy alone. The Paxman Limb Cryocompression System delivers controlled cooling and intermittent pressure to the arms and legs during chemotherapy infusions. Participants will undergo screening, in-clinic device sessions coinciding with chemotherapy, and complete questionnaires at prespecified visits to track neuropathy symptoms, tolerability, and safety. The FDA has not approved this device for prevention of peripheral neuropathy and patients with prior neuropathy, cold-sensitive blood disorders, lymphedema, or open limb wounds are excluded.
Who should consider this trial
Good fit: Adults over 18 with breast or gynecologic malignancy starting their first cycle of specified taxane-based chemotherapy regimens who are treated at Dana-Farber's main campus and can complete questionnaires in English or Spanish are the ideal candidates.
Not a fit: Patients with pre-existing neuropathy, prior exposure to neurotoxic chemotherapy, cold-related disorders, lymphedema or open limb wounds, or those treated outside the Dana-Farber main campus are unlikely to qualify or benefit from this intervention.
Why it matters
Potential benefit: If successful, cryocompression could reduce the risk or severity of chemotherapy-induced peripheral neuropathy, improving patient comfort and the ability to complete planned chemotherapy.
How similar studies have performed: Prior work on limb and scalp cooling has suggested some reduction in taxane-related neuropathy, but evidence is limited and not definitive for this specific device and approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Theresa Jabaley Leonarczyk, PhD, RN — Dana-Farber Cancer Institute
- Study coordinator: Theresa Jabaley Leonarczyk, PhD, RN
- Email: theresa_jabaley@dfci.harvard.edu
- Phone: 617-582-8037
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.