The US 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. The device, also called a «cold cap», is the first of its kind to be approved for patients with solid tumours.
“We are pleased to expand access of this device to patients with solid tumours, helping to mitigate the hair loss that chemotherapy can cause,” said Dr Binita Ashar, director of the Division of Surgical Devices in 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 effect of some chemotherapy treatments, especially in cases of solid tumours. This loss can range from a reduction in density to total hair loss. Although in most cases temporary, minimising 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. The device, known as a cold cap, is operated by a computerised 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 optimises cooling efficiency.
Cooling constricts the blood vessels in the scalp, reducing the amount of chemotherapy that reaches the hair follicles. It also slows down the cellular activity of these follicles, decreasing their susceptibility to treatment. Together, these actions could minimise hair loss. However, the system may not be effective for all chemotherapy treatments.
In 2015, the FDA cleared the cooling system for use in breast cancer patients. The approval was based on a study of 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 submitted additional data supporting its safety and efficacy in other types of solid tumours.
The system is not suitable for paediatric patients, those with certain types of cancer or those receiving specific chemotherapy treatments. In addition, people with sensitivity to cold or at increased risk of cold injury should avoid using the system. Common side effects include headaches, neck and shoulder discomfort, and some discomfort from prolonged use of the cold cap.
Although the risk of chemotherapy being less effective in the treated area due to the use of the device is low, the possible long-term effects of cooling and its relationship to metastasis in this area have not been fully investigated.
The FDA granted this authorisation to Dignitana Inc., the manufacturer of the cooling system.
The FDA, part of the US Department of Health and Human Services, oversees the safety and effectiveness of drugs, medical devices, food, cosmetics and related public health products, as well as regulating tobacco and other electronic products that emit radiation.
