Breast cancer patients undergoing chemotherapy may soon keep their scarves and hats deep into their closets. On Tuesday, the Food and Drug Administration cleared a cold cap device that prevents alopecia or hair loss, which is a very common side effect of chemotherapy.
Most cancer patients, if not all, are worried about losing their hair in the process of treatment. The amount of hair loss in just a few sessions of chemotherapy tantamount to an entire year of growing it back.
The stigma of women wearing hats and scarves on their head also raises important concerns. Dr. Hope Rugo from the University of California, San Francisco said such pieces of clothing have served as markers that something is wrong with the women who wear it.
DigniCap Cooling System, manufactured by Swiss company Dignitana Inc., was tested by Rugo and colleagues on 122 patients at four different medical facilities. All the participants were diagnosed with early-stage breast cancer and were recommended to undergo chemotherapy.
First, the patients were assisted to wear a tight-fitting cap that is attached to a cooling device. The device chilled the scalp, but not freeze it. The administration of the chemotherapeutic drugs started 30 minutes after the cool cap has been placed.
The patient wore the device throughout the entire session and approximately an hour and a half later, when the blood levels of the drugs started to decline.
Over two-thirds of the patients maintained more than 50 percent of their hair.
“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, Office of Device Evaluation’s acting director at the Center for Devices and Radiological Health of the FDA.
Scalp cooling has been going around for decades. Subjecting the scalp at low temperatures momentarily decreases blood flow and cell metabolism, thus, preventing the chemotherapeutic drugs from reaching and damaging the hair follicles.
DigniCap Approval: An FDA First
Although several cool cap devices are marketed all around the world, the DigniCap is the first product that FDA cleared for marketing for breast cancer patients in the U.S.
Dignitana AB will be leasing its products to several cancer treatment facilities so their patients can try it on.
The company said the device has been tested in various countries such as Japan, Germany and Russia, among others. Now, it is excited to market the DigniCap across the U.S.
“We are tremendously excited to be able to offer this state-of-the-art technology to hospitals and infusion centers across the U.S.,” said Jan Richardsson, the chief executive officer of Dignitana AB.