FDA Approves 'Cold Cap' That Reduces Hair Loss During Chemo

The U.S. Food and Drug Administration has approved a new treatment that partially alleviates one of the most striking effects of chemotherapy: hair loss.

The treatment is called the Dignitana DigniCap Cooling System and consists of a computer-controlled device that circulates cold liquid to a cooling cap worn during chemotherapy treatment. The FDA has cleared it for use in female breast cancer patients only. This was the group included in the clinical trial that led to the treatment's approval.

"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," Dr. William Maisel, acting director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health said in a statement Tuesday announcing the clearance.

DigniCap works by constricting blood vessels in the scalp, impeding chemotherapy from penetrating hair follicles. The treatment, which originated in Sweden, is already available in several European countries, Australia, New Zealand and others.

In the U.S. clinical trial, seven out of 10 patients with early stage breast cancer receiving the treatment kept at least 50 percent of their hair. No adverse effects were reported, but the treatment is only for solid tumor cancers, not blood-based ones because metastasis in the scalp was a concern.

Donna Tookes was one of the patients participating in the trial in the U.S. The Connecticut resident was diagnosed with breast cancer in January of 2014. After undergoing a mastectomy of her right breast, she was prescribed chemotherapy.

"I didn't have a choice. There was no option for me," Tookes told ABC News. "In preparing for chemo, the first thing you think is am I gonna live? Are my children going to be OK? Will they have me in their lives? Then, I will lose my hair."

Her husband wrote a letter to doctors at Mt. Sinai Beth Israel, who were participating in the trial. He asked them to include Tookes in it. When they agreed, he had to convince his wife.

"The whole thing was really started based on a love letter my husband wrote based on what he felt about me and my hair," the 60-year-old said, adding her thick black-and-silver hair is her "trademark."

"For me, everybody, women in particular, this is our crown of glory, our hair," she said. "It's just so much a part of us and just to keep that and walk around and not upset people. ... I could deal with it more than other people seeing me [without hair]."

Tookes, who is in remission, underwent 12 chemotherapy treatments using the DigniCap. She didn't lose any hair, she said.

"At first it's like a brain freeze, but after you get used to it really fast and they give you blankets to keep you warm," she said.

The DigniCap costs around $400 to $500 per chemotherapy treatment. Dignitana CEO Jan Richardson told ABC News that once the treatment becomes widely available, chemotherapy infusion centers that lease the equipment from the company will determine the price of using the device.

The company hopes to do additional trials in the country so that the treatment can be used in patients facing other types of cancer.

Dr. Tessa Cigler, a medical oncologist at the Weill Cornell Breast Center, said the treatment could be a huge advance.

"Hair loss is probably the most dreaded of all the side effects of chemotherapy. There's women who refuse treatment because of hair loss," Cigler, whose group participated in the trial, told ABC News. "Being able to preserve one's hair during chemotherapy is very empowering."