US FDA approves hair loss-fighting cap for cancer patients
The U.S. Food and Drug Administration cleared for marketing in the United States the first cooling cap to reduce hair loss (alopecia) in female breast cancer patients undergoing chemotherapy.
“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,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “Managing the side effects of chemotherapy is a critical component to overall health and recovery.”
The Dignitana DigniCap Cooling System 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. It 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 (hair roots). 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. Interested patients should talk with their doctors.
Prevention of hair loss in these patients may be a significant benefit to their quality of life, and the risk of the chemotherapy drug missing an isolated grouping of the breast cancer cells in the scalp because of the cold cap is extremely rare.
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.
Category: Features, Technology & Devices
