FDA Expands Cooling Cap Alopecia Approval to Cover Solid Tumors

Binita Ashar, MD

The FDA has expanded the indication for the DigniCap Cooling System to be used for alopecia reduction across all solid tumors, according to a statement from the FDA. The device had previously been approved solely for reducing severe hair loss in patients with breast cancer.

The initial approval in breast cancer, which was granted in 2015, was based on an analysis of 122 women with stage I/II breast cancer who were undergoing alopecia-inducing chemotherapy. Results of the open-label, nonrandomized study showed that more than 66% of the women who used the device lost less than 50% of their hair. None of the patients in the control arm met this milestone. Additional findings were also submitted for those with other solid tumors, for the expanded approval. These data were similar to the breast cancer results, according to the FDA.

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

The cooling cap, manufactured by Sweden-based Dignitana, circulates cold liquid through a silicone cap that is worn on the head during treatment with chemotherapy. The cap is connected to a unit that distributes the cooled liquid that is controlled using touchscreen prompts. A second cap made of neoprene holds the initial cap in place and prevents loss of cooling.

The near-freezing temperatures are intended to constrict the blood vessels in the scalp, making it difficult for toxic chemotherapy agents to reach and harm the hair follicles. The cold also decreases the activity of the hair roots, which slows down cell division and makes them less affected by chemotherapy. The FDA noted that "risk of the chemotherapy drug missing an isolated grouping of the cancer cells in the scalp because of the cooling cap is rare." The agency added, however, that the "long-term effects of scalp-cooling and risk of scalp metastasis have not been fully studied."

In the breast cancer study, patients had an average age of 53.0 years (range, 28-77). Patients were treated with docetaxel/cyclophosphamide (75%), docetaxel/carboplatin (12%), weekly paclitaxel (12%), and docetaxel (1%). Patients also received HER2-targeted therapy along with docetaxel/carboplatin and docetaxel.

In the DigniCap group, 5% of patients did not lose any hair compared with 0% in the chemotherapy arm. Additionally, 30.7% of patients in the DigniCap arm had less than 25% hair loss, compared with none in the control group. Just 14.9% of patients in the DigniCap arm lost more than 75% of their hair compared with 93.8% in the control arm.

By chemotherapy utilized, those receiving docetaxel/carboplatin had an 83.3% success rate, defined as less than 50% hair loss. Those receiving docetaxel/cyclophosphamide had a 60.2% success rate, and those treated with a taxane alone had an 83.3% success rate.

The most common adverse events associated with the cooling cap were cold-induced headaches and neck and shoulder discomfort, chills, and pain associated with wearing the cooling cap for an extended period. Three patients in the breast cancer study discontinued using the cooling cap due to cold discomfort. Forty-one percent of women had at least 1 headache while using the cooling cap.