The Food and Drug Administration has cleared for marketing the first cooling cap to reduce alopecia for female patients with breast cancer undergoing chemotherapy, the Dignitana DigniCap Cooling System. It is indicated to reduce the frequency and severity of alopecia during chemotherapy in breast cancer patients in which alopecia-inducing chemotherapeutic agents and doses are used.
“We are pleased to see a product for breast cancer patients that can minimize chemotherapy-induced hair loss and contribute to the quality of life of these individuals,” William Maisel, MD, MPH, Acting Director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, said in a news release. “Managing the side effects of chemotherapy is a critical component to overall health and recovery.”
How It Works
The device is a computer-controlled system that circulates cooled liquid to a head-worn cooling cap during chemotherapy treatment. The cooling cap is covered by a second cap made from neoprene, which holds the cooling cap in place and acts as an insulation cover to prevent loss of cooling.
The cooling action is intended to constrict blood vessels in the scalp, which, in theory, reduces the amount of chemotherapy that reaches cells in the hair follicles. The cold also decreases the activity of the hair follicles, which slows down cell division and makes them less affected by chemotherapy. The combined actions are thought to reduce the effect chemotherapy has on the cells, which may reduce hair loss. DigniCap may not work with some chemotherapy regimens, however, the FDA notes.
The efficacy for the device was evaluated in a study of 122 women with stages I or II breast cancer who were undergoing chemotherapy that have been recognized as being associated with hair loss. The data from this study may also be applied to some Stage III and IV breast cancer patients because they may have a benefit-risk profile comparable to the patients enrolled in this study, the FDA noted.
According to a self-assessment of hair loss by the women using standardized photographs at an average of one month after the last chemotherapy cycle, more than 66 percent of the patients treated with the DigniCap reported losing less than half their hair.
The most common side effects of the cooling system include cold-induced headaches and neck and shoulder discomfort, chills, and pain associated with wearing the cooling cap for an extended period of time.
De Novo Classification
The FDA reviewed data for the DigniCap cooling system through the de novo classification process, a regulatory pathway for some low- to moderate-risk devices that are novel and not substantially equivalent to any legally marketed device.
The device is manufactured by Dignitana Inc.
Clinical Quick Facts: DigniCap Cooling System
Device: DigniCap Cooling System
Approved Indication: To reduce the frequency and severity of alopecia during chemotherapy in breast cancer patients in which alopecia-inducing chemotherapeutic agents and doses are used
Common Side Effects: Cold-induced headaches and neck and shoulder discomfort, chills, and pain associated with wearing the cooling cap for an extended period of time