Hair loss can be a devastating side effect of chemotherapy, but the recent U.S. Food and Drug Administration (FDA) approval of the DigniCap Cooling System and the growing acceptance of scalp-cooling methods in the United States may improve the quality of life for many patients receiving chemotherapy.

Our challenge was convincing the FDA of the importance of preventing hair loss. They were worried it wasn’t feasible, but we were able to demonstrate excellent feasibility and efficacy.

— Hope S. Rugo, MD

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At the 2016 Multinational Association on Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) International Symposium on Supportive Care in Cancer in Adelaide, Australia, Hope S. Rugo, MD, Director of Breast Oncology and Clinical Trials Education at the University of California San Francisco Helen Diller Family Comprehensive Cancer Center, offered an overview of the current scalp-cooling methods available to patients undergoing chemotherapy as well as future directions in this burgeoning area.

“Scalp cooling has, historically, not been available in the United States, mainly because there was concern this wasn’t an effective method of preventing hair loss and also there were potential risks of increased scalp metastases and thermal injury,” said Dr. Rugo. “There were also issues with space, time, and funding, but on the other side, the patient interest was substantial.”

Corina van den Hurk, PhD, a postdoctorate researcher in clinical oncology and epidemiology at the Netherlands Comprehensive Cancer Organisation in Utrecht, further commented: “The general view of health-care professionals is always ‘it’s only cosmetic, it’s not life threatening, and there are wonderful wigs, so why bother?’ But if we ask patients about it, they say hair loss breaks their spirit; it’s a reminder of illness every time they look in the mirror, and they feel a loss of their sense of self.”

Most Frequently Used Devices

DigniCap is a self-contained system that circulates coolant through a tight-fitting silicone cap, with temperature sensors connected to the cooling and control unit. According to Dr. Rugo, this system is highly effective in reducing chemotherapy-induced alopecia, with clinically meaningful benefit.

The DigniCap system was granted FDA clearance in December 2015, based on the results of a pivotal trial led by Dr. Rugo. The system prevented hair loss in 66.3% of patients with breast cancer who received neo/adjuvant chemotherapy, compared with the control group (patients who opted out of scalp cooling entirely), all of whom experienced significant hair loss.¹ The treatment was also found to be safe and well tolerated. Mean follow-up is now at 2.5 years, with plans to continue, and no patients have developed scalp metastases. Of note, patients enrolled in the study had stage I or II breast cancer and were receiving taxane-based chemotherapy regimens. Patients receiving sequential or concurrent anthracycline and taxane therapy were not included.

“Our challenge was convincing the FDA of the importance of preventing hair loss,” revealed Dr. Rugo. “They were worried it wasn’t feasible, but we were able to demonstrate excellent feasibility and efficacy.”

Another cooling system, Penguin Cold Caps, consists of patented, insulated gel caps, which must be cooled in a freezer or on dry ice to –35°C before use. Since patients can rent the caps themselves—ie, medical centers do not have to provide them—they have been the most frequently used device in the United States until recently.

However, use of Penguin Cold Caps may not be as simple as the use of the DigniCap system, since their temperature must be carefully regulated, they require a special freezer or dry ice, and helpers must be present for the duration of treatment to fit and change the caps every 30 minutes. Additionally, the number of cold caps required is dependent on the type and duration of chemotherapy administration. Caps must be rented for the duration of treatment.

The Paxman Hair Loss Prevention System is similar to the DigniCap system and is currently being tested in a U.S. randomized trial. “This trial will provide safety and efficacy data that will be an important addition to the body of prospective data on scalp cooling,” she added.

One consideration for patients who are contemplating the use of scalp cooling is the monetary cost. “Scalp cooling can be quite costly in the United States, with no clear difference in expense between different cooling systems as yet,” revealed Dr. Rugo. In other countries, scalp cooling is incorporated into the overall cost of treatment, whereas in the United States, this cost is usually borne by the patients themselves. Attempts have been made to address this issue of cost in the United States, so more patients may benefit from scalp cooling.

What Are the Risks?

In the short term, patients sometimes complain about a cold sensation, or “brain freeze,” and headache from scalp cooling. Dermatitis of the scalp and skin thermal injuries are rare and have only been described with frozen caps, such as the Penguin Cold Caps, she added.

The main concern in the long term has been the increased risk of scalp metastases due to the possibility of constricted blood vessels limiting the amount of chemotherapy reaching the scalp. However, according to Dr. Rugo, “the data have fairly definitively shown that there isn’t an increased risk from scalp cooling.”

First, she noted that the potential for scalp metastases does not square with what is understood about the biology of breast cancer. “If breast cancer cells were going to hide out in the scalp, and that’s where you were going to get your recurrence, you should see a lot of scalp metastases as the first event in metastatic progression,” she pointed out.

“Second, of course, scalp cooling isn’t that good,” she added. “Everybody loses some hair, so you’re clearly getting chemotherapy to the scalp.” According to Dr. Rugo, when scalp metastasis does occur, it is often concomitant with other sites of disease recurrence. “Numerous studies in scalp-cooled patients suggest no difference in risk,” she reiterated.

Where Are We Now?

Dr. Rugo emphasized the need to better inform patients and oncology providers about scalp-cooling options. The improvement of scalp-cooling technology is also critical, as are the coordination of access, insurance coverage, and post-cooling time issues, or “chair time.”

“Cost is a big issue in the United States, where patients have to pay out of pocket. So when we started using the DigniCap machines just a few months ago, we spent a lot of time trying to cap the cost, so patients didn’t have to pay every single time,” she revealed. An organization called HairToStay.org also enlists donations for patients who need help paying for scalp cooling. “We don’t want this just to be an option for people who have money and access.”

“Alopecia is important to many patients and deserves attention,” added Dr. van den Hurk. “We should study more on the mechanism of scalp cooling and maybe use a more patient-tailored approach, taking a look at personal scalp skin temperature to improve the results.”

Dr. van den Hurk and her colleagues have established a group called CHILL (Cancer-Related Hair Loss International Leadership and Linkage) to share knowledge and encourage global research and collaboration to improve patient care. ■

Disclosure: Drs. Rugo and van den Hurk reported no potential conflicts of interest.

Reference

1. Rugo H, et al: 2016 MASCC/ISOO International Symposium. Presented June 23, 2016.