Cooling Cap Approved for Chemotherapy-Related Alopecia

The DigniCap Cooling System reduces the frequency and severity of alopecia during chemotherapy in breast cancer patients.

Hair loss is a very common side effect experienced by patients undergoing chemotherapy, especially with some of the agents used in the treatment of breast cancer. Although temporary, and associated with the period of drug use, alopecia can significantly contribute to the patient's feeling of well being and could be a hindrance to a good quality of life.

To alleviate this side effect, a company in Sweden, Dignitana Inc, has manufactured a device called the DigniCap Cooling System, which reduces the frequency and severity of alopecia during chemotherapy in breast cancer patients. The device circulates cooled liquid to a cooling cap to be worn on the head during chemotherapy administration. The cooling effect constricts blood vessels in the saclp, thereby restricting access of the chemotherapy agent to hair follicles in the patient's scalp.

“We are pleased to see a product for breast cancer patients that can minimize chemotherapy-induced hair loss and contribute to the quality of life of these individuals,” said William Maisel, MD, MPH, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “Managing the side effects of chemotherapy is a critical component to overall health and recovery.”

The device was approved today by the FDA.