The Dignitana Cooling System cap has been approved by the U.S. Food and Drug Administration to help prevent hair loss in women undergoing chemotherapy for breast cancer.
A computer-controlled system circulates cooled liquid to the cap during chemotherapy. This is designed to constrict blood vessels in the scalp, limiting the amount of chemotherapy drugs that reach the hair follicles, the agency said in a news release.
In clinical testing, more than two-thirds of women who wore the cap reported losing less than half of their hair. And the likelihood of chemotherapy drugs missing an isolated cluster of breast cancer cells in the scalp because of the cap was “extremely rare,” the FDA said.
But since the cap doesn’t work with all chemotherapy drugs, any woman interested in using the product should speak with her doctor, the FDA advised.
The most common side effects of the cap included headache, neck and shoulder pain, chills and pain associated with wearing the cap for extended periods.
The product is produced by Dignitana Inc., based in Lund, Sweden.
The FDA has more about this approval.
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