Prevention of Paclitaxel Neuropathy With Cryotherapy
Overview
- Phase
- Phase 2
- Intervention
- Cryotherapy
- Conditions
- Breast Cancer
- Sponsor
- Medical Oncology & Hematology Associates of Northern Virginia
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Incidence of grade 2 peripheral neuropathies induced by weekly paclitaxel.
- Last Updated
- 10 years ago
Overview
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.
Investigators
Mary Wilkinson
Principle Investigator
Medical Oncology & Hematology Associates of Northern Virginia
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: 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.
Intervention: Paclitaxel
Outcomes
Primary Outcomes
Incidence of grade 2 peripheral neuropathies induced by weekly paclitaxel.
Time Frame: From the date of randomization until date of first documented incidence of grade 2 peripheral neuropathy, assessed up to 2 years.
Secondary Outcomes
- 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.)