FDA Extends Cooling Cap Use to Patients With Solid Tumors
The cap should not be used on children, patients with certain cancers, and those having specific kinds of chemotherapy.
(HealthDay News) — A cooling cap approved in 2015 for use in breast cancer patients has received expanded approval from the US Food and Drug Administration.
The DigniCap Cooling System can now be used for patients with solid tumors, the FDA announced. The computer-controlled cap contains liquid that circulates and cools the scalp, narrowing blood vessels. This reduces how much of the chemotherapy drugs reach hair follicle cells, the FDA said. Cooling also decreases activity of hair follicles and slows cell division.
But the cap isn't for everyone. It may not work with some treatment regimens. And it should not be used on children, patients with certain cancers, and those having specific kinds of chemotherapy, the FDA said. In addition, the agency said, the cap may not be suited for patients with cold sensitivity or susceptibility to cold-related injuries.
Common side effects of the cap include cold-induced headaches, neck and shoulder discomfort, chills, and pain. Wearing it is not likely to cause chemotherapy drugs to miss some cancer cells in the scalp, according to the FDA. However, the long-term effects of scalp-cooling and risk of cancer spread have not been fully studied, the agency said.
- FDA clears expanded use of cooling cap to reduce hair loss during chemotherapy [press release]. US Food & Drug Administration. July 3, 2017.