Cooler Heads Care Inc.
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.
Alopecia
Chemotherapy-induced Alopecia
Hair Loss
Breast Cancer
Gynecologic Cancer
AMMA Portalbe Scalp Cooling System
Not Applicable
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.
Study Type : | Interventional |
Estimated Enrollment : | 0 participants |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | A Pilot Study to Evaluate the Use of the AMMA Portable Scalp Cooling System |
Actual Study Start Date : | August 15, 2022 |
Estimated Primary Completion Date : | June 30, 2023 |
Estimated Study Completion Date : | September 30, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Interventional All patients will use AMMA |
Device: AMMA Portalbe Scalp Cooling System |
Ages Eligible for Study: | 21 Years |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
White Plains Hospital
White Plains, New York, United States, 10601