Prevention of Paclitaxel Neuropathy With Cryotherapy
- Registration Number
- NCT02230319
- Lead Sponsor
- Medical Oncology & Hematology Associates of Northern Virginia
- Brief Summary
The purpose of this study is to determine if cryotherapy can effectively decrease the rate of neuropathy in patients undergoing weekly paclitaxel treatments.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 39
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cryotherapy Cryotherapy Each patient will receive cryotherapy administered during weekly paclitaxel treatments by Elasto gel™ Hypothermia mitts and slippers. Patients will wear the mitts and slippers for 15 minutes prior to treatment start, for 60 minutes during treatment, and for 15 minutes following treatment completion, for a total of 90 minutes. Cryotherapy Paclitaxel Each patient will receive cryotherapy administered during weekly paclitaxel treatments by Elasto gel™ Hypothermia mitts and slippers. Patients will wear the mitts and slippers for 15 minutes prior to treatment start, for 60 minutes during treatment, and for 15 minutes following treatment completion, for a total of 90 minutes.
- Primary Outcome Measures
Name Time Method Incidence of grade 2 peripheral neuropathies induced by weekly paclitaxel. From the date of randomization until date of first documented incidence of grade 2 peripheral neuropathy, assessed up to 2 years.
- Secondary Outcome Measures
Name Time Method Rate of completion of weekly adjuvant paclitaxel with the use of cryotherapy. From the date of randomization until date of first documented incidence of grade 2 peripheral neuropathy, assessed up to 2 years.
Trial Locations
- Locations (1)
Medical Oncology & Hematology Associates of Northern Virginia
🇺🇸Reston, Virginia, United States