Study of the Lily Device to Reduce Hair Loss from Chemotherapy in Adults with Breast Cancer Evaluating Safety and Effectiveness During 4 Chemotherapy Cycles

What this Trial Is About

Researchers are evaluating the Lily Device to see if it can reduce hair loss caused by chemotherapy in adults with breast cancer stages 1 to 3. The study also aims to assess the safety of the device by monitoring any adverse events related to its use. The main questions focus on whether patients preserve their hair after four chemotherapy cycles and the occurrence of any device-related side effects. Participants will use the Lily Device during each chemotherapy session. The device must be worn during the chemotherapy infusion and for at least two hours, up to four hours, after the infusion ends. The study includes at least four cycles of chemotherapy, with various chemotherapy regimens allowed. The devices use is monitored throughout the chemotherapy treatment period. Study participants will be assessed after four chemotherapy cycles for hair preservation by both healthcare professionals and patients themselves. Researchers will collect photographs of the scalp, ask participants to complete quality of life questionnaires, and track how well participants follow the device wear schedule. Safety is closely monitored from enrollment until 30 days after the last treatment, looking for any adverse device events or serious side effects.

The Lily Device Trial