FDA approves DigniCap Cooling System for use in cancer patients with solid tumors- Dignitana

The FDA has cleared the expanded use of a cooling cap, DigniCap Cooling System, from Dignitana , to reduce hair loss (alopecia) during chemotherapy. This is the first cooling cap cleared by the agency for use in cancer patients with solid tumors. The DigniCap Cooling System is indicated to reduce the frequency and severity of hair loss during chemotherapy in solid tumor cancer patients in which alopecia-inducing chemotherapeutic agents and doses are used.

It is a computer-controlled system used during treatment. A cap is worn on the head and circulates liquid to a cap to cool the scalp during chemotherapy treatment. The cap is covered by a second cap made from neoprene, a type of rubber that holds the cooling cap in place and acts as an insulation cover to prevent loss of cooling. The most common side effects of the cooling system include cold-induced headaches and neck and shoulder discomfort, chills and pain associated with wearing the cooling cap for an extended period of time. The risk of the chemotherapy drug missing an isolated grouping of the cancer cells in the scalp because of the cooling cap is rare.

In 2015, the FDA granted marketing authorization of the DigniCap for use in patients with breast cancer. For that authorization, the efficacy of the cooling system was studied in 122 Stage I and Stage II women with breast cancer who were undergoing chemotherapy, using recognized chemotherapy regimens that have been associated with hair loss. That study demonstrated that more than 66 percent of patients treated with the DigniCap reported losing less than half their hair. In support of the expanded use of the device, the manufacturer also submitted evidence from published, peer-reviewed articles that analyzed the application of the DigniCap to cancer patients with solid tumors in other areas of the body besides the breast. The FDA concluded that these studies provided valid scientific evidence to support the safety and efficacy of the expanded indication for the DigniCap.