The United States Food and Drug Administration (FDA) has approved the expanded use of a cooling system, known as scalp cooling technology, to help reduce hair loss (alopecia) caused by chemotherapy. This device, also called a «cold cap,» is the first of its kind to receive authorization for patients with solid tumors.
«We are pleased to expand access to this device for patients with solid tumors, helping to mitigate hair loss that chemotherapy can cause,» said Dr. Binita Ashar, Director of the Division of Surgical Devices at the FDA’s Center for Devices and Radiological Health. «Managing the side effects of chemotherapy 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 a reduction in hair density to complete hair loss. Although in most cases it is temporary, minimizing this impact is an important aspect of comprehensive cancer treatment.
The cooling system is designed to reduce the severity of alopecia in patients receiving chemotherapeutic agents that induce this effect. This device, 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 external neoprene cap that keeps the device in place and optimizes cooling efficiency.
Cooling constricts the blood vessels of the scalp, reducing the amount of chemotherapy that reaches the hair follicles. Additionally, it slows down the cellular activity of these follicles, decreasing their susceptibility to treatment. Together, these actions could minimize hair loss. However, the system may not be effective for all chemotherapy treatments.
In 2015, the FDA authorized the use of the cooling system for patients with breast cancer. The approval was based on a study with 122 women in early stages of the disease, in which more than 66% reported retaining at least half of their hair. To expand the device’s indication, the manufacturer presented additional data supporting its safety and efficacy for other types of solid tumors.
The system is not suitable for pediatric patients, those with certain types of cancer, or those receiving specific chemotherapy treatments. Additionally, people with cold sensitivity or at greater risk of cold-related injuries should avoid its use. The most common side effects include headaches, discomfort in the neck and shoulders, and some discomfort resulting from prolonged use of the cold cap.
Although the risk that chemotherapy will be less effective in the area treated by the device is low, the possible long-term effects of cooling and its relationship with metastasis in this area have not been fully investigated.
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 medications, medical devices, food, cosmetics, and health-related products, and also regulates tobacco and other electronic products that emit radiation.
