The FDA has cleared the expanded use of a cooling cap, DigniCap Cooling System, to reduce hair loss during chemotherapy. This is the first cooling cap cleared by the agency for use in cancer patients with solid tumors.
The system is indicated to reduce the frequency and severity of hair loss during chemotherapy in solid tumor cancer patients in which alopecia-inducing chemotherapeutic agents and doses are used.
In 2015, the FDA granted marketing authorization of the DigniCap for use in patients with breast cancer. For that authorization, the efficacy of the cooling system was studied in 122 stage I and stage II women with breast cancer who were undergoing chemotherapy, using recognized chemotherapy regimens that have been associated with hair loss. That study demonstrated that more than 66 percent of patients treated with the cooling cap reported losing less than half their hair.
In support of the expanded use of the device, evidence was also submitted from published, peer-reviewed articles that analyzed the application of the system to cancer patients with solid tumors in other areas of the body besides the breast. The FDA concluded that these studies provided valid scientific evidence to support the safety and efficacy of the expanded indication.