This clinical trial tests the safety and effectiveness of the Amma Portable Scalp Cooling System (PSCS) in preventing hair loss during certain chemotherapy treatments in women with stage I-III breast cancer. Breast cancer is the second most common form of cancer in women in the United States. Hair loss is a side effect of some chemotherapy treatments which can have a negative effect on self-image and self-esteem. In fact, up to 8% of patients choose not to undergo chemotherapy due to possible hair loss. Scalp cooling lowers the temperature of the scalp causing the blood vessels to narrow to reduce the amount of chemotherapy delivered to the hair follicles and may prevent hair loss. The Amma PSCS is a portable unit which allows patients to leave the infusion center after chemotherapy is completed and finish scalp cooling at home. The Amma PSCS may be safe and effective in preventing hair loos in women receiving chemotherapy for stage I-III breast cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT06215469.
Locations matching your search criteria
United States
California
San Francisco
University of California San FranciscoStatus: Active
Contact: Hope S. Rugo
Phone: 415-353-7618
PRIMARY OBJECTIVES:
I. To evaluate hair loss as assessed by the investigator at 3 weeks (±1 week) after the completion of the last chemotherapy (CT) treatment/infusion visit using the Common Terminology Criteria for Adverse Events (CTCAE) by comparing post-treatment photographs to pre-treatment photographs.
SECONDARY OBJECTIVES:
I. To determine the safety of the Amma PSCS based on the occurrence of device-related adverse events, occurrence of scalp changes determined by physical examination, and patient symptoms with use of the PSCS.
II. To evaluate hair loss as measured by the patient at 3 weeks (±1 week) after the completion of the last treatment/infusion visit by comparing post-treatment photographs to baseline photographs.
III. To assess tolerability/compliance with use of the PSCS.
IV. To assess patient quality of life and satisfaction with hair preservation after usage of the Amma PSCS device via the Body Image Scale (BIS) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire- Breast 23 (EORTC-QLQ-BR23) questionnaire.
OUTLINE:
Patients wear Amma PSCS on scalp continuously starting 30 minutes before CT infusion and up to 2 hours after each cycle of CT throughout study.
After completion of study intervention, patients are followed up for at least 30 days.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of California San Francisco
Principal InvestigatorHope S. Rugo
