FDA Expands Indication for Cooling Cap to Reduce Chemotherapy-Related Hair Loss

The FDA recently approved an expanded indication for the use of the DigniCap Cooling System to lessen chemotherapy-induced hair loss. This is the first cooling cap approved for use among patients with solid tumors, according to 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, 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.”

Hair loss is commonly experienced by patients with solid tumors due to the type of chemotherapy used to treat the condition. Hair loss may be gradual, happen in sections, or hair may become thin during therapy, according to the release.

While hair loss is typically temporary, the FDA reports that reducing these side effects is important for patients.

The DigniCooling System is indicated to reduce hair loss during chemotherapy among patients with solid tumors who are receiving alopecia-inducing treatments.

The cooling cap is controlled by a computer and is worn on the head during treatment. The cap circulates liquid to cool the scalp and is covered by a neoprene second cap to prevent movement and cooling loss, according to the release.

The cooling constricts blood vessels in the scalp, which reduces the uptake of chemotherapy by the hair follicles. The temperature also slows down cell division and activity of the hair follicles. These mechanisms are thought to reduce the drug’s effect on hair loss.

Importantly, the FDA notes that the cooling cap will likely not cause chemotherapy to miss an isolated group of cancer cells in the scalp.

“We know that many patients struggle as they experience chemotherapy-induced hair loss associated with breast and other solid tumors” said Mario Lacouture, MD, director of the Oncodermatology Program at Memorial Sloan Kettering Cancer Center. "Scalp cooling is clinically proven and can be an important component in selected chemotherapy regimens in various tumor types, in patients for whom preventing hair loss is important for their well-being.”

In 2015, the FDA authorized the cap for use among patients with breast cancer due to positive results from a study that included 122 women with stage 1 and 2 breast cancer receiving chemotherapy known to cause hair loss. The study showed that more than 66% of patients lost less than half of their hair.

To support the expanded indication, the manufacturer, Dignitana AB, submitted findings from studies that examined the efficacy of the DigniCap System in patients with solid tumors, according to the release. The FDA found that the evidence supported the expanded indication, according to the release.

The FDA warns that the device should not be used by pediatric patients, those with certain cancers, and those receiving certain treatments. The cooling cap may also not be suitable for patients with susceptibility to cold-related injuries or cold sensitivity.

Common side effects include cold-induced headaches, neck and shoulder discomfort, chills, and pain associated with long-term utilization of the cap, according to the release.

“Scalp cooling is recognized around the world as a safe and effective therapeutic solution to one of the most traumatic side effects of chemotherapy,” said Johan Ericsson, chief executive officer of Dignitana AB. “Dignitana takes great pride in our ability to lead the way and remain at the cutting edge of technological developments that provide a transformative quality of life experience for people coping with a cancer diagnosis. This FDA decision allows us to help even more patients in the US as they navigate life with the disease.”