FDA Expands Indication for Scalp Cooling Device to Reduce Hair Loss

The use of a cooling cap to reduce alopecia during chemotherapy has been expanded beyond breast cancer to other solid tumors.

The US Food and Drug Administration (FDA) announced the expanded use of a cooling cap, the DigniCap Cooling System, in a press release.

“We are pleased to expand the use of this product for cancer patients with solid tumors to potentially minimize chemotherapy-induced hair loss,” said Binita Ashar, MD, director of the division of surgical devices in the FDA’s Center for Devices and Radiological Health. “Managing the side effects of chemotherapy is a critical component to overall health and quality of life.”

The DigniCap Cooling System is a computer-controlled system used during chemotherapy. A cap worn on the head circulates liquid to cool the scalp during treatment. The cap is covered by a second cap made from neoprene to hold the cooling cap in place and insulate against cooling loss.

The cooling constricts blood vessels in the scalp, which reduces the amount of chemotherapy that reaches cells in the hair follicles. Cold temperature also decreases the activity of the hair follicles and slows down cell division, making them less affected by chemotherapy.

DigniCap may not work with some chemotherapy regimens, the FDA noted.

In 2015, the FDA granted marketing authorization of the DigniCap for use in patients with breast cancer. For that authorization, studies of women with breast cancer who were undergoing chemotherapy using recognized regimens that have been associated with hair loss demonstrated that more than 66% of patients treated reported losing less than half of their hair.

A recent prospective cohort study found that the use of scalp cooling was associated with reduced hair loss at 4 weeks after the last dose of chemotherapy among women undergoing non–anthracycline-based adjuvant chemotherapy for early-stage breast cancer. The multicenter study found that two-thirds of patients reported hair loss of 50% or less in a scalp cooling group vs no patients in a control group, as well as quality-of-life benefits for the scalp cooling group.

The FDA analyzed published, peer-reviewed articles of the DigniCap in cancer patients with solid tumors in other areas of the body besides the breast, and concluded that these studies provided valid scientific evidence to support the safety and efficacy of the expanded indication.

They noted that the device is contraindicated for pediatric patients, patients with some certain cancers, and patients undergoing some specific chemotherapy treatments. Additionally, it may not be appropriate for patients with cold sensitivity or susceptibility to cold-related injuries.

The most common side effects of the cooling system include cold-induced headaches and neck and shoulder discomfort, chills, and pain associated with wearing the cooling cap for an extended period of time. The risk of the chemotherapy drug missing an isolated grouping of cancer cells in the scalp because of the cooling cap is rare, they noted, adding that long-term effects of scalp cooling and risk of scalp metastasis have not been fully studied.