Study of the Portable Scalp Cooling System to Prevent Hair Loss in Women Undergoing Chemotherapy for Early to Mid-Stage Breast Cancer

What this Trial Is About

Researchers are evaluating the Portable Scalp Cooling System AMMA PSCS to prevent hair loss in women undergoing chemotherapy for early-stage breast cancer stages I-III. This prospective, multi-center study also aims to assess the safety, tolerability, patient compliance, quality of life, and satisfaction with hair preservation after chemotherapy treatment. The study focuses on women receiving taxane-containing chemotherapy regimens intended to be completed within six months. The AMMA device is designed for use during chemotherapy infusion, transport from the infusion center to home, and at home. Patients will be trained to use the device and asked to bring it to each chemotherapy session. The device is used 30 minutes before chemotherapy starts, throughout the chemotherapy infusion, and for at least 2.5 hours after the treatment. Scalp photos will be taken at the start and after the last chemotherapy session to evaluate hair loss. Participants will be monitored through electronic health records and prospective data collection. Assessments include safety evaluations, scalp changes, patient symptoms, and tolerability, along with patient-reported outcomes on hair loss, satisfaction, and quality of life using standard scales. The primary outcome is hair loss measured three weeks after treatment, with additional follow-up on device-related effects and patient quality of life. The study will continue until at least three weeks after the last chemotherapy treatment.

Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss