The FDA Just Approved a New Treatment That Reduces Hair Loss During Chemotherapy

//The FDA Just Approved a New Treatment That Reduces Hair Loss During Chemotherapy

It’s already stressful to come to terms with a breast cancer diagnosis, but losing your hair during chemotherapy treatment can cause so much distress for any patient. Fortunately, there’s now a device that women can use to regain some form of normalcy in their lives during treatment.

Last Tuesday, for the first time, the FDA approved a scalp cooling system, Dignitana DigniCap Cooling System, which reduces hair loss in female breast cancer patients undergoing chemotherapy. The cap, made by Swedish manufacturer, Dignitana Inc, is intended to reduce the frequency and severity of alopecia during chemotherapy. Operated by a computer-controlled system, the cap circulates cooled liquid to a cooling cap during chemo. A second cap is placed over the cooling cap, which holds it in place and serves as insulation to prevent the loss of coolness.

The FDA described the process in their release, saying, “The cooling action is intended to constrict blood vessels in the scalp, which, in theory, reduces the amount of chemotherapy that reaches cells in the hair follicles (hair roots). The cold also decreases the activity of the hair follicles, which slows down cell division and makes them less affected by chemotherapy. The combined actions are thought to reduce the effect chemotherapy has on the cells, which may reduce hair loss.”


According to Dignitana, 7 out of 10 patients with early stage breast cancer kept at least 50 percent of their hair. For one clinical trial participant, Deanna King, none of her hair fell out.

“I had 100 percent success rate,” King says. “I was very fortunate. I was on the right chemo regimen and my hair didn’t fall out at all. Had my scalp not frozen, all of my hair would have fallen out.”

For breast cancer patients, this was a way to regain control. King told, “I started doing research and what I wanted to do is try to have some control over my treatment plan. You know I wanted to be really proactive and advocate for myself.”

Dr. Hope Rugo, principal investigator for the study and director of Breast Oncology and Clinical Trials Education at the UCSF Helen Diller Family Comprehensive Cancer Center, explained that this cap can be used for different cancers as well. “It’s not as if, for example, someone with an ovarian cancer can’t use it. They could; it’s just that the FDA gives specific approval to what you studied in your trial. But you can certainly use it and it’s being used worldwide for other cancers. We don’t recommend it for liquid tumors like leukemia because [tumor cells are] everywhere at once and it would be very hard for it to work.”

There are currently different non-FDA approved cooling caps being used on the market, such as the Penguin Cooling Cap, which you have to freeze and change the cap every 30 minutes. The Penguin Cap, however, is manufactured with FDA-approved materials.

King was enthusiastic about the DigniCap specially since there was less room for human error, which would make the process ineffective. “It’s a device where people who use cold caps have to have another person changing the caps all the time and making sure they’re the right temperature, so there’s a lot more room for error. It’s much harder to do. Whereas this is an actual machine and all you have to do is just sit there.”

The FDA noted that side effects included cold-induced headaches, neck and shoulder discomfort, and chills and pain associated with wearing the cap for a long period of time.

CBS News spoke to Dignitana’s chief operating officer, Bill Cronin, who said that depending how many rounds of chemo a woman would goes through, the total cost of using the cap could be between $1,500 to $3,000.

Dignitiana is currently finalizing their agreements with major centers and community oncology groups across the country so DigniCaps will be available to patients as soon as possible.