The DigniCap Cooling System, previously approved solely for patients with breast cancer, is now cleared for the prevention of hair loss for those with other solid tumors, according to a statement from the U.S. Food and Drug Administration (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 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 percent of the women who used the device lost less than 50 percent of their hair. All patients lost greater than 50 percent of their hair in a control arm. Additional findings were also submitted for those with other solid tumors, for the expanded approval. These data were like the breast cancer results, according to the FDA.
In the breast cancer study, patients had an average age of 53.0 years (range, 28-77). Patients were treated with docetaxel/cyclophosphamide (75 percent), docetaxel/carboplatin (12 percent), weekly paclitaxel (12 percent), and docetaxel (1 percent). Patients also received HER2-targeted therapy along with docetaxel/carboplatin and docetaxel.
In the DigniCap group, 5 percent of patients did not lose any hair compared with 0 percent in the chemotherapy arm. Additionally, 30.7 percent of patients in the DigniCap arm had less than 25 percent hair loss, compared with none in the control group. Just 14.9 percent of patients in the DigniCap arm lost more than 75 percent of their hair compared with 93.8 percent in the control arm.
By chemotherapy utilized, those receiving docetaxel/carboplatin had an 83.3 percent success rate, defined as less than 50 percent hair loss. Those receiving docetaxel/cyclophosphamide had a 60.2 percent success rate, and those treated with a taxane alone had an 83.3 percent 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.