FDA Approves Cooling Cap Across Solid Tumors

Binita Ashar, MD, director, Division of Surgical Devices, in the FDA’s Center for Devices and Radiological Health

Binita Ashar, MD

The indication for the DigniCap Cooling System has been expanded by the FDA to include alopecia reduction across all solid tumors. The cooling cap system was previously only indicated for reducing hair loss in patients with breast cancer.

The initial breast cancer approval, which was granted in 2015, was based on a study showing that 66% of those utilizing the cooling cap lost less than 50% of their hair. No patients met this criteria in the control arm. Additional findings were also submitted to the FDA for those with other solid tumors, although the FDA did not disclose details.

“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.

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.