A cooling cap worn on the head during chemotherapy to minimize hair loss is now available for use in the United States by patients with any type of solid tumor.
The DigniCap scalp cooling system (developed by Dignitana) is already marketed for use by breast cancer patients to prevent chemotherapy-induced hair loss, having been approved for that indication by the US Food and Drug Administration (FDA) in December 2015.
"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, 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 new indication is for use of the product to reduce the frequency and severity of hair loss during chemotherapy in solid tumor cancer patients for which alopecia-inducing chemotherapeutic agents and doses are used, the FDA noted. To support the expanded indication, the manufacturer submitted evidence from published, peer-reviewed articles, and the FDA concluded that these studies provide valid scientific evidence to support the safety and efficacy of the expanded indication.
The product consists of a cap worn on the head which is connected to a computer system that circulates liquid to the cap to cool the scalp during chemotherapy treatment.
The cooling is intended to constrict blood vessels in the scalp, which reduces the amount of chemotherapy that reaches cells in the hair follicles, the FDA explained. The cold temperature also decreases the activity of the hair follicles and slows down cell division, making them less affected by chemotherapy.
The combined actions are thought to reduce the effect of chemotherapy on cells in the hair follicles, which may reduce hair loss, the agency said in its notice.
The FDA noted that efficacy of the product was assessed in previous trials in breast cancer patients, which led to initial approval in that patient population. For that authorization, the product was tested in 122 patients with stage 1 and 2 breast cancer who were undergoing chemotherapy using regimens associated with hair loss. The study demonstrated more than 66% of patients treated with the DigniCap reported losing less than half their hair, the agency noted.
At the time the product was approved for use in breast cancer patients, Medscape Medical News spoke to an investigator involved in that clinical trial, who emphasized the huge impact hair loss can have on patients.
"Hair loss with chemotherapy is the most dreaded side effect," commented Tessa Cigler, MD, MPH, from the Weill Cornell Breast Center in New York City, New York, where 30 breast cancer patients were treated with the DigniCap.
Some women refuse to have it, while others comprise the type of chemotherapy they receive to avoid hair loss, she said. Generally the most active chemotherapy for early stage breast cancer, which includes anthracyclines and taxanes, are associated with hair loss, she added, and these women are compromising the effectiveness of their prevention treatment.
"Hair loss is so much greater than vanity," Dr Cigler commented. "It is linked to a woman's sense of well-being, self-esteem, sense of control, and privacy," she added. Some are women who want to keep working through their treatment, others are mothers who do not want their children to know they are undergoing treatment.
The device is contraindicated for pediatric patients, patients with certain cancers, and those undergoing specific chemotherapy treatments, the FDA noted. Additionally, DigniCap may not be appropriate for patients with cold sensitivity or susceptibility to cold-related injuries.
The most common side effects include cold-induced headaches, neck and shoulder discomfort, and chills and pain associated with wearing the cooling cap for an extended period.
The risk of chemotherapy missing an isolated group of cancer cells in the scalp because of the cooling cap is rare, the agency noted, but adds that the long-term effects of scalp cooling and risk of scalp metastasis have not been fully studied.