December 09, 2015
1 min read

FDA clears cooling system for chemotherapy-associated hair loss

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The FDA has cleared the first cooling cap for the reduction of hair loss in women undergoing chemotherapy for breast cancer.

The DigniCap Cooling System (Dignitana Inc.) is designed to reduce the frequency and severity of alopecia in women received alopecia-inducing chemotherapy as treatment for breast cancer. It uses a computer-controlled system that circulates cooled liquid to a head-worn 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 is believed to reduce 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 FDA based its clearance on a study of 122 women with stage I or stage II breast cancer undergoing chemotherapy regimens associated with hair loss. Self-assessment of hair loss based on photographs taken approximately one month after the final dose served as the primary endpoint. Approximately 66% of women reported losing less than half of their hair when using the cooling cap.

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, according to a press release from the cap’s manufacturer.

The FDA reported that the risk for chemotherapy agents missing an isolated grouping of breast cancer cells in the scalp due to the cold cap was extremely rare.

Adverse events associated with the use of the cooling cap included cold-induced headache, neck and should discomfort, chills, and pain associated with wearing the cap. Further, the manufacturer noted that the cap’s effect may not be generalizable to all chemotherapy regimens.

“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 press release. “Managing the side effects of chemotherapy is a critical component to overall health and recovery.”