Cooling caps can preserve hair for patients with breast cancer undergoing chemotherapy.
Jill Allington was a 35-year-old mother of an almost 2-year-old son when she was diagnosed with breast cancer two years ago. Nursing her son one night, she had an itch on her chest wall. When she scratched it, she felt a little lump — “like a pea,” she says.
It turned out to be a tumor. Two weeks later, she was in surgery. In shock, Allington’s first thoughts were of her son. “He was at the age where he’d snuggle up with me and twirl my hair while he nursed,” she says. “I wanted to minimize his discomfort and keep up appearances for him.”
That desire led Allington to look into scalp cooling to preserve her hair while she was undergoing chemotherapy with docetaxel, carboplatin and treatment with the targeted drug Herceptin (trastuzumab). Also sometimes referred to as “scalp hypothermia” or “cold cap therapy,” this technique involves cooling the scalp for a period of time before, during and after each chemotherapy treatment. As the scalp is cooled, blood vessels constrict and metabolic activity in the hair follicles slows, which is thought to lessen the amount of drugs reaching the hair follicles and help prevent or reduce hair loss. The technique seems to work best in women like Allington, whose chemotherapy regimens do not include an anthracycline, like doxorubicin.
Allington used Penguin Cold Caps, a product of the U.K.-based Medical Specialties of California UK Ltd., for her scalp cooling treatment — a product that has not received U.S. Food and Drug Administration (FDA) approval. According to the company’s website, the lack of FDA approval means the company cannot sell caps to patients; rather, patients with many types of cancer who are being treated with chemotherapy are allowed to rent the cold caps and related equipment monthly and use them at their own risk. Allington traveled to her infusion appointments with the caps in two coolers, each filled with 40 pounds of dry ice; her husband, John, took responsibility for maintaining the temperature of the caps and for helping his wife change the caps every 30 minutes, starting approximately one hour before her infusion began and continuing throughout the duration of her treatment and for four hours after her infusion ended.
“My cancer treatment center didn’t stop me from using the caps, but they didn’t encourage me,” Allington says, adding that staff told her they could not assist with the caps. “Once we got going, they were my cheerleaders.”
THE LATEST COLD CAP OPTION
Now, women being treated for breast cancer have a new cold cap option. In December 2015, Sweden-based Dignitana AB’s DigniCap system was cleared for marketing in the U.S. by the FDA specifically for use in breast cancer patients who are receiving chemotherapy. A similar system, the Paxman Scalp Cooling System, has not received FDA clearance at this time, but is available for use by patients with breast cancer at some U.S. cancer centers in New Jersey, Ohio and Texas as part of a phase 3 clinical trial that is still recruiting participants (NCT01986140).
While DigniCap aims for hair preservation as do manual devices like Penguin Cold Caps and Elasto-Gel caps, which are also not FDA-approved, the DigniCap system uses a single silicone cap connected to an automated cooling and control unit. Sensors at the front and back of the cap maintain the right amount of coolant coming through the cap, according to Bethany Hornthal, consultant to Dignitana and to Quantum Leap Healthcare Collaborative, a non-profit partner of the Breast Care Center at the University of California at San Francisco (UCSF), which recently completed a study of the DigniCap scalp cooling system.
The multi-center study, led by Hope S. Rugo, professor of medicine and director of Breast Oncology and Clinical Trials Education at the UCSF Helen Diller Family Comprehensive Cancer Center, investigated the effectiveness of DigniCap in 122 women with stage 1 and 2 breast cancer who were undergoing chemotherapy at one of five academic medical centers in the U.S. More than 66 percent of patients treated with the DigniCap system reported losing less than half their hair, based on a self-assessment of hair loss one month after their last chemotherapy cycle. The results of that study led the FDA to clear the DigniCap system for marketing in the U.S. through its de novo classification process for low- to moderate-risk novel devices.
According to Hornthal, FDA clearance paves the way for infusion centers to be trained in fitting the caps — meaning that patients like Allington won’t have to accept full responsibility for their cold cap therapy or rely on outside helpers. “The infusion center will lease the machine and staff will be trained” in assisting patients, says Hornthal. So far, 13 cancer centers have signed agreements to use DigniCap, and agreements are pending with dozens more, according to a recent company press release. Hornthal adds that the company plans to try to expand its FDA clearance for marketing to patients with other types of cancer, especially solid tumors, that are treated with chemotherapy.
That’s good news, says Allington, who relied on instructions from the manufacturer and online videos to learn how to use her Penguin Cold Caps. She and her husband “practiced on our family room floor” to get the timing and fitting of the caps down, she says, adding that she kept her hair and considers her use of cold caps successful.
CONSIDERING THE PRICE TAG
According to Hornthal, costs for the DigniCap system — which range from $1,500 to $3,000 for the duration of an individual’s chemotherapy treatment — will be set by the individual infusion center. “The center will lease the system and a per-use fee will be charged,” she says, adding that Dignitana has engaged an expert to help gain reimbursement from insurance companies to defray the cost of treatment. The expert is also working to create local and national #HairToStay Funds to help subsidize the cost of treatment.
Chemo Cold Caps — which uses caps made by Elasto-Gel — along with related equipment can be rented for $650 a month, and Penguin Cold Caps and related equipment can be rented monthly for about $580, according to company websites. Patients interested in using cold caps but concerned about price might consider an approach like buying several reusable Elasto-Gel caps, available online for about $100 each, one or two large coolers and, before each infusion, some dry ice (available at some grocery stores and priced at $1 per pound on one specialty website). But patients who go this route will need a friend or family member to provide help — as Allington’s husband did — in monitoring the temperature of the caps and changing them every 30 minutes.
Patients can also ask staff members at their treatment facilities whether anyone, after completing chemotherapy, has donated reusable cooling caps for others to use.
MAKING THE DECISION
promising for breast cancer patients considering scalp cooling, the therapy isn’t without discomfort — or possible risk. “It was so cold, especially when you first put it on,” Allington says, adding that she dressed in warm clothes and used an electric blanket during her treatment. “But it did get progressively easier with each cap change. It’s cold and it hurts, but it doesn’t hurt forever.”
Changing the cap every 30 minutes also meant she couldn’t sleep through her chemotherapy, as many patients do. That’s one of the benefits of DigniCap, says Hornthal. “An automated system is much more convenient for the patient,” she says.
Aside from patient discomfort, additional concerns about scalp cooling have been raised — particularly concerns about future scalp metastases. J. Leonard Lichtenfeld, deputy chief medical officer for the American Cancer Society, says the issue is whether using a cold cap creates a “sanctuary” for tumor cells. “The object of adjuvant chemotherapy is to attack cancer cells where they reside and to get all the cancer cells early to prevent a recurrence,” he says. “The FDA has said there’s a very small chance of a tumor recurring in the scalp, but the studies done are not long-term studies that would answer questions about recurrence.”
In a recent blog post, Lichtenfeld also questioned the exclusion from the study of women who had received doxorubicin, an anthracycline, which he called one of the “most toxic drugs when it comes to hair loss,” but one that is commonly used in adjuvant chemotherapy for breast cancer. In studies of Penguin Cold Caps, patients who took an anthracycline plus a taxane had the lowest rate of successful hair preservation, at 36 percent, according to the company’s website.
Rugo, lead investigator of the Dignitana study, says that scalp metastases are “extraordinarily rare in breast cancer, and are even rarer as the first site of metastasis.” As for the issue of which drugs are likely to work well with DigniCap, the study shows that a substantial number of women taking the regimens most commonly prescribed for breast cancer — including docetaxel and cyclophosphamide (TC), docetaxel, carboplatin and trastuzumab (TCH), and weekly paclitaxel — successfully used scalp cooling therapy to maintain hair, she says. Additional studies are ongoing to evaluate scalp cooling in patients receiving doxorubicin, Rugo notes, and prior studies indicate scalp-cooling effectiveness, although at a lower rate than with less toxic regimens.
Disclaimers on product websites clearly state that scalp cooling will not be effective in preventing hair loss for all patients undergoing chemotherapy. In addition, women who opt for scalp cooling need to be gentle with their hair, limiting shampooing and avoiding coloring, heat styling and excessive brushing for the duration of their treatment, according to BreastCancer.org.
While difficult at times, Allington, who says her husband’s grandmother, Ginny, generously covered the total $3,000 cost of her scalp cooling therapy, says she would choose scalp cooling again.
“Having hair gave me the opportunity to not have every conversation I had be about cancer,” she says.
Given unanswered questions about efficacy with all chemotherapy drugs and the questions raised by some in the oncology community about the potential for scalp metastases, Lichtenfeld says women considering scalp cooling therapy should discuss the option with their oncology care teams.
“I believe strongly in patients with cancer having full information and participating in decisions about their own care,” he says. “The best decision is the right decision for that individual.