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FDA clears expansion of cooling cap to reduce hair loss in patients with solid tumors
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The FDA cleared the expanded use of the DigniCap Cooling System to reduce hair loss during chemotherapy to include all patients with solid tumors.
Scalp cooling — achieved by wearing a cooling cap that circulates refrigerated liquid — reduces blood flow to hair follicles, reducing the amount of chemotherapy that reaches them. The cold temperature also slows down cell division, making hair follicles less affected by chemotherapy.
The FDA previously cleared the DigniCap Cooling System (Dignitana Inc) to reduce the frequency and severity of alopecia in women undergoing alopecia-inducing chemotherapy for breast cancer.
“We are pleased to expand the use of this product for cancer patients with solid tumors to potentially minimize chemotherapy-induced hair loss,” Binita Ashar, MD, director of the division of surgical devices in the FDA’s Center for Devices and Radiological Health, said in a press release. “Managing the side effects of chemotherapy is a critical component to overall health and quality of life.”
To support the device’s expanded use, Dignitana submitted evidence from published, peer-reviewed articles with data on the use of the DigniCap in patients with solid tumors in other areas of the body besides the breast.
As a result, the FDA concluded that these studies provided valid scientific evidence to support the safety and efficacy of the expanded indication for the cooling system.
The most common side effects included cold-induced headaches and neck and shoulder discomfort, as well as chills and pain associated with wearing the cooling cap for an extended period of time. Long-term effects of scalp-cooling and risk for scalp metastasis have not been fully studied.