'Cooling Cap' FDA-Approved In U.S. To Prevent Hair Loss During Chemotherapy

The U.S. Food and Drug Administration recently approved a new device that will help prevent hair loss in some women undergoing chemotherapy for breast cancer.

The new cooling cap, called the DigniCap Cooling System, is produced by the Swedish company Dignitana. The FDA's decision was based on clinical trials involving 122 Stage I and Stage II women with breast cancer undergoing chemotherapy regimens associated with hair loss. Findings showed that Dignicap helped prevent hair loss in two-thirds of patients.

"Hair loss from chemo is probably ranked among the most dreaded side effects of chemotherapy," said Dr. Tessa Cigler, assistant professor of medicine at the Weill Cornell Breast Center who was involved in the testing of the device. "I think this will make such a difference in so many women's lives."

The computer-controlled device works by circulating cooled liquid while a patient receives chemotherapy. The cold works to constrict blood vessels in the scalp in order to help reduce toxic chemicals reach the hair roots. The cap was worn for just about 30 minutes before starting chemotherapy, according to The Washington Post, and then, patients wore the cap during treatment and 30 to 60 minutes following.

"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, acting director of FDA's office of device evaluation, said in a news release. "Managing the side effects of chemotherapy is a critical component to overall health and recovery."

However, health officials noted that the device may not work with all chemotherapy regimens and may also come with some side effects, including chills, cold-induced headaches and neck and shoulder discomfort.

To learn more about the device, visit the company's website, here.

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