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Brief Title: A Pilot Study to Evaluate the Use of the AMMA Portable Scalp Cooling System From Cooler Heads
Official Title: A Pilot Study to Evaluate the Use of the AMMA Portable Scalp Cooling System
Study ID: NCT05365243
Brief Summary: Eligible patients will be recruited prior to initiation of chemotherapy for any stage breast or gynecologic cancer. Patients will undergo training in the use of the AMMA Portable Scalp Cooling System and will use the device during each of their chemotherapy treatments. Quality of life and experience of use questionnaires will be completed. Scalp photos and an assessment of hair loss will be preformed at enrollment and at the end of study participation.
Detailed Description: AMMA is designed to be used by patients in the chemotherapy infusion center, during transport from the infusion center to home, and after arrival at home. Patients will participate in training in AMMA use and will be asked to bring the device to the chemotherapy infusion center for use during each chemotherapy treatment visit. The device will be used for 30 minutes prior to the start of chemotherapy, during chemotherapy and for 2 hours after chemotherapy. Scalp photos will be obtained at baseline and after the last chemotherapy treatment. Patients will be asked to complete the following questionnaires: training evaluation after training is complete; and symptoms from device use, experience with device use and self-assessment of hair loss after each chemotherapy treatment.
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
White Plains Hospital, White Plains, New York, United States
Name: Kate Dilligan
Affiliation: Cooler Heads Care Inc.
Role: STUDY_DIRECTOR