Cold Comfort: Cooling Caps Can Preserve Hair for Patients Undergoing Chemotherapy

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.”


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.

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