The Food and Drug Administration (FDA) has given the green light for marketing DigniCap in the U.S, announcing Tuesday that the cap will be made available to women with breast cancer who are undergoing chemotherapy.
DigniCap reduces chemo hair loss, or alopecia. Chemotherapy often results in hair loss, making the hair thin in some areas of the scalp or making the hair fall out completely. While alopecia is just a temporary side effect of cancer treatment, preventing or minimizing it is "important to overall treatment," the agency said in a press release.
"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 Dr. William Maisel, FDA's acting director of the Office of Device Evaluation. "Managing the side effects of chemotherapy is a critical component to overall health and recovery."
DigniCap lessens chemotherapy-induced hair loss by cooling the scalp. The low temperature reduces blood flow and prevents chemotherapy to reach the hair cells. The cooling effect also slows down the hair's cellular metabolism, keeping the hair from being exposed to the full strength of chemotherapy, according to manufacturer Dignitana.
Some side effects associated with the use of the cooling cap include headaches and discomfort in the neck and shoulders caused by the cold temperature and chills. Some patients feel pain when they wear the cap for an extended period of time.
The cap is fitted with sensors that regulate the temperature and ensure that it does not go below the freezing point during cancer treatment.
Oncologist Dr. Tessa Cigler from the Weill Cornell Breast Center was one of the doctors involved in the trial. She said that the DigniCap could help convince some women who reject chemotherapy for fear of hair loss to undergo cancer treatment.
"Hair loss is probably the most dreaded of all the side effects of chemotherapy," she told ABC News. "There's women who refuse treatment because of hair loss. Being able to preserve one's hair during chemotherapy is very empowering."
