The FDA announced Tuesday the de novo clearance for the marketing of the nation’s first cooling cap — the Dignitana DigniCap Cooling System — to reduce the severity and frequency of hair loss in patients receiving chemotherapy for breast cancer.
The decision was based on a study of 122 women with stage 1 and stage 2 breast cancer undergoing alopecia-inducing chemotherapy. More than 66 percent of the women who used the DigniCap lost less than half of their hair and no severe adverse events were reported.
“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 Center for Devices and Radiological Health’s Office of Device Evaluation, said in a statement. “Managing the side effects of chemotherapy is a critical component to overall health and recovery.”
The de novo classification process provides a pathway for low- to moderate-risk devices for which no equivalent marketed devices exist.
The cooling cap, manufactured by Sweden-based Dignitana, is a computer-controlled device that circulates cold liquid through a silicone cap that is worn on the head during chemotherapy treatment. The cap is connected to a unit that distributes the cooled liquid as well as a control unit with touch screen prompts. A second cap made of neoprene holds the initial cap in place and prevents loss of cooling.
The near-freezing temperatures are intended to constrict the blood vessels in the scalp, making it difficult for the toxic chemotherapy drugs to reach and harm the hair follicles. The cold also decreases the activity of the hair roots, which slows down cell division and makes them less affected by chemotherapy.
The authors noted that the results from the study suggest that the benefits of the cooling cap may also apply to patients with stage 3 and 4 breast cancer.
“Some of today’s most powerful, life-saving chemotherapy treatments still cause complete hair loss, a side effect that many women consider to be emotionally devastating,” lead investigator Hope S. Rugo, director of Breast Oncology and Clinical Trials Education, UCSF Helen Diller Family Comprehensive Cancer Center, said in a statement. “This FDA clearance means that for many cancer patients in the U. S., chemo-induced hair loss will no longer be a distressing concern.”
The primary endpoint of the study was a self-assessment of hair loss by the women, who photographed their hair three to six weeks after their last chemotherapy treatment. The results showed a mean patient-reported satisfaction score of 87.5 percent, nearly 80 percent for hair quantity and 69 percent satisfaction for hair quality.
The most common adverse events reported after using the cooling cap included cold-induced headaches, neck and shoulder discomfort, chills and pain.
The cost of the cooling cap will be decided by the providing medical facility, but Dignitana said on its website that the company is negotiating with insurance companies and working to engage philanthropic organizations and corporate sponsors.