Up until recently, hair loss was inevitable for those undergoing chemotherapy. The side effect is particularly troubling for the many patients who feel being bald strips them of their dignity and identity, and is a clear marker to the outside world that they are sick.

The DigniCap Scalp Cooling System—a cold, temperature regulated cap that a patient can wear during chemotherapy to reduce the chance of hair loss—offers a potential solution.

“We really value our privacy here in the United States,” said Melissa Bourestom, vice president of marketing at Dignitana, the company that created the DigniCap Scalp Cooling System, in an interview with Drug Discovery & Development. “We don’t want people to just see us and say, she doesn’t have any hair, therefor something is wrong with her; she must have cancer. A lot of patients will tell us that it is huge for them to be looked at as themselves and not as a cancer patient.”

The basic concept of cooling the scalp to prevent hair loss during chemotherapy is not new; healthcare providers have been using cold packs or ice for this purpose for years, said Bourestom. It was a nurse in Sweden who wanted to find a more controlled and clinical way to give the treatment that first envisioned the DigniCap system. It was launched in Sweden in 2007 and received U.S. FDA clearance for women with breast cancer in December 2015. Today it is available worldwide.

The DigniCap Scalp Cooling System. Photo provided by DigniCap

How it works

The DigniCap system consists of a snug-fitting silicone cooling cap connected to a cooling and control unit which is worn before, during, and between 90 to 120 minutes after chemotherapy is given. An outer insulating cap of neoprene is also applied over the silicone cap to ensure the cold cannot escape.

The coolant circulates through channels in the cap and sensors in the cap monitor scalp temperature, allowing the system to automatically regulate cooling temperature throughout the treatment. A sensor in the cap ensures that the temperature never drops below 32 degrees Fahrenheit. The machines don’t require any intervention from the patient or healthcare provider and can cool two patients at the same time on either side of the machine.

The technique relies on basis basal constriction, explained Dr. Hope Rugo, M.D. the lead investigator on the clinical trial that led to the FDA clearance of DigniCap, in an interview with Drug Discovery & Development. “The real reason why scalp cooling is effective is because the cooling really reduces the metabolism of the hair follicle cells,” said Rugo, professor of Medicine and director of Breast Oncology and Clinical Trials Education at the University of California San Francisco Helen Diller Family Comprehensive Cancer Center. “The hair follicle is squeezed off where it exits from the follicle when chemotherapy is causing hair loss, and they get really, really thin at that spot because the follicle is busy speeding up its metabolism to try and make do with the toxin. In this case, we reduce that effect by cooling the cells.”

The study that led to the FDA clearance looked at 117 breast cancer patients with either stage I or stage II breast cancer who underwent at least four cycles of specific chemotherapy regimens.

Of the patients that used the DigniCap Scalp Cooling System in the study, 66.3 percent lost less than half of their hair when followed for a month after the last chemotherapy cycle. In comparison, 100 percent of women in the control group who did not use the system lost more than half of their hair.

Side effects were found to be minimal with the treatment.

“We found that the treatment was very tolerable. The side effects were exactly what you would expect if you put a really cold cap on your head; a headache, a sense of being cold,” said Rugo. “We allow patients to ask for pain medication right before their start to deal with that initial cooling or the ‘brain freeze’ that they feel at the start. Then they adjust to the cold, and it doesn’t bother them so much anymore”

Obstacles to furthering its use

There is a significant interest in the DigniCap system, but it has been slow to take off in the U.S., said Bourestom.

“We get emails almost every day from patients that say, ‘I’m starting chemotherapy next week, I want to use it, send it to my doctor,’” she said. “Unfortunately because it is medical equipment it is not quite that easy. But we are working to get it out there.”

The system is currently available in 67 centers across 19 states, with new centers being added often. Expense is a factor for some patients, as the system costs between $1,500-$3,000 to use depending on a patient’s chemotherapy regimen and needs. At this time, most insurance companies are not covering it, but some persistent patients have had success gaining reimbursement, said Bourestom. DigniCap is working with insurance companies to try to improve coverage rates.

“It is a very important goal for the future to try and get insurance coverage, or at least partial insurance coverage for scalp cooling so that it is not a technique that can only be used by people who can afford it,” said Rugo.

DigniCap has also partnered with philanthropic organization Hair to Stay, which raises money to help fund patients that are low income that want to use scalp cooling.

Future plans

At this time, the device is not cleared in the U.S. for patients with cancers other than breast cancer, and it is not cleared for men with breast cancer. However, patients all over the world with numerous types of cancers have had success using it.

Currently DigniCap is talking with the FDA about the possibility of expanding FDA clearance.

“We are evaluating what the next steps of that will be,” said Bourestom. “We are hoping to expand it to include all patients with solid state tumors that are treated with the same classes of drugs. This is something that patients really want.”