The United States Food and Drug Administration (FDA) has approved the expanded use of a cooling system, known as a scalp cooling system, to help reduce hair loss (alopecia) caused by chemotherapy. This device, also referred to as a “cold cap,” is the first of its kind to be authorized for patients with solid tumors.
“We are pleased to expand access to this device for patients with solid tumors, helping to mitigate the hair loss caused by chemotherapy,” said Dr. Binita Ashar, director of the Division of Surgical Devices at the FDA’s Center for Devices and Radiological Health. “Managing chemotherapy side effects is key to improving patients’ quality of life.”
Hair loss is a common side effect of certain chemotherapy treatments, especially in cases of solid tumors. This loss can range from thinning hair to complete baldness. Although hair loss is usually temporary, minimizing this impact is an important part of comprehensive cancer care.
The cooling system is designed to reduce the severity of alopecia in patients undergoing chemotherapy treatments that cause this side effect. This device, also known as a cold cap, works through a computerized system that cools the patient’s head. During treatment, patients wear a special cap through which a cooling liquid circulates, accompanied by an outer neoprene cap that keeps the device in place and optimizes cooling efficiency.
Cooling constricts the blood vessels in the scalp, reducing the amount of chemotherapy that reaches the hair follicles. It also slows the activity of these follicles, making them less susceptible to damage from treatment. Together, these actions may help minimize hair loss. However, the system may not be effective for all chemotherapy regimens.
In 2015, the FDA approved the use of the cooling system for patients with breast cancer. The approval was based on a study involving 122 women in early stages of the disease, where more than 66% reported retaining at least half of their hair. To support the device’s expanded use, the manufacturer provided additional data from published studies demonstrating its safety and effectiveness in other types of solid tumors.
The system is not suitable for pediatric patients, individuals with certain types of cancer, or those undergoing specific chemotherapy treatments. Additionally, people with sensitivity to cold or a higher risk of cold-related injuries should avoid using it. Common side effects include headaches, neck and shoulder discomfort, and mild pain related to prolonged use of the cold cap.
While the risk of chemotherapy being less effective in the treated area due to the device is low, the long-term effects of cooling and its potential link to scalp metastasis have not been thoroughly studied.
The FDA granted this authorization to Dignitana Inc., the manufacturer of the cooling system.
The FDA, part of the U.S. Department of Health and Human Services, oversees the safety and efficacy of drugs, medical devices, food, cosmetics, and public health-related products, as well as the regulation of tobacco and radiation-emitting products.
