Official Title
Prevention of Paclitaxel Neuropathy With Cryotherapy
Phase
Phase 2Study Type
InterventionalStatus
Unknown statusIndication/Condition
Breast CancerIntervention/Treatment
paclitaxel ...Study Participants
39The purpose of this study is to determine if cryotherapy can effectively decrease the rate of neuropathy in patients undergoing weekly paclitaxel treatments.
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.
Inclusion Criteria Women 18 years of age or older Histologically or cytological proven diagnosis of breast cancer Stage I- III. Must pl an to receive weekly paclitaxel treatment in either the adjuvant or neoadjuvant setting. May have received prior treatment including, radiation, surgery chemotherapy hormone and biologics. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 Patient signed informed consent. Patient willing and able to comply with scheduled visits and treatment plan. Exclusion Criteria Patient presents with Grade 2 or greater peripheral neuropathy. History of Raynaud's Disease. Patient presents open or poorly-healing wounds on the hands or feet. Patients with cold intolerance. Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment contraindicate patient participation.
