Cryocompression to prevent taxane-induced nerve damage in the arms and legs.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Non-invasive brain stimulation to help chemotherapy-induced nerve problems in cancer survivors

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.