DigniCap Scalp Cooling System Now Approved for Use in All Solid Tumors

The FDA has approved expanding the use of the DigniCap Cooling System, a cooling cap that reduces hair loss (alopecia) during chemotherapy. The cap, previously approved only for use in breast cancer patients, is now cleared for all patients with solid tumors.

Hair loss is a common side effect of chemotherapy treatment; however, the cooling cap is capable of reducing this effect by restricting the blood vessels in the scalp and minimizing the amount of treatment that reaches the hair follicles.

The cap circulates liquid to cool the scalp during chemotherapy treatments, then a second neoprene cap is placed on the head to act as insulation and maintain the cool temperature. The low temperature of the cap slows down cell division and the activity of the hair follicles, thereby lessening the effect of the chemotherapy on hair loss.

In 2015, the FDA approved use of the DigniCap in breast cancer patients following a study 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. Use of the cooling system resulted in 66% of patients reporting loss of less than half their hair. The continuation of these studies and the inclusion of patients with solid tumors in other regions led the FDA to expand their approval.

Digitana Inc’s DigniCap Cooling System was the first cooling device to be FDA approved in 2015; however, this form of alopecia prevention has expanded. In April, the FDA approved of a similar device, the Paxman Scalp Cooling System, for breast cancer patients following results of a JAMA study.

Side effects of the cooling cap included cold induced headaches and discomfort, however long term effects have not yet been determined. The device is contraindicated for pediatric patients, patients with certain cancers and patient undergoing specific chemotherapy treatments. Additionally, DigniCap may not be appropriate for patients with cold sensitivity or susceptibility to cold-related injuries.

“We are pleased to expand the use of this product for cancer patients with solid tumors to potentially minimize chemotherapy-induced hair loss,” concludes Binita Ashar, M.D., 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.”

The device is manufactured by Dignitana Inc.