Cooling Cap Trial to Prevent Permanent Chemotherapy-induced Alopecia in Breast Cancer Patients

"The investigational device which will be used in this study is the Paxman Scalp Cooling System 2. This device is manufactured by: Paxman Coolers Limited. This is a free-standing, electrically-powered, mobile refrigeration unit which circulates a refrigerated liquid coolant, at a pre-set temperature and flow rate, through a cooling cap which is attached to, and covers, the top of the patient's head. The Paxman Scalp Cooling System is intended to be used for scalp cooling of patients who are receiving chemotherapy for the treatment of solid tumors, in order to reduce the risk of chemotherapy-induced alopecia.~After the RCT, 34 patients who were expected to receive 4, 6, or 8 cycles of chemotherapy with an anthracycline regimen were further enrolled in the intervention group as a single-arm trial."