Evaluating the Use of Limb Cryocompression to Reduce Taxane-induced Peripheral Neuropathy
Dana-Farber Cancer Institute
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)
Description
This randomized controlled trial 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. There is evidence that cooling therapy may be effective for preventing peripheral neuropathy caused by taxane-based chemotherapy. The U.S. Food and Drug Administration (FDA) has not approved the PAXMAN Limb Cryocompressio…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 * Pr…
Interventions
- DevicePaxman 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
Location
- Dana-Farber Cancer InstituteBoston, Massachusetts