The Federal Drug Administration (FDA) of the United States has approved the start of a multicenter trial of the DigniCap System, a scalp-cooling device for chemotherapy-related hair loss. A pilot study at the University of California, San Francisco and Wake Forest Baptist Medical Center found the treatment to be successful and well-tolerated for the majority of women.
The trial will enroll 110 patients at major medical center in the USA, including the above centers plus 2 sites in New York, and one additional one in California. The DigniCap System features a tight-fitting silicone cap that is placed directly on the head, and an outer neoprene cap that insulates and secures the inner one. A coolant circulates throughout the inner silicone layer, delivering consistent cooling to all areas of the scalp. When the cap is applied, the scalp temperature drops and blood vessels surrounding hair roots shrink, leading to a reduction in cell-killing chemicals (cytotoxins) to the follicle: Reduced blood flow means less chemotherapy hits the hair follicle.
My take: Historically, we have been concerned that cooling caps might allow cancer cells to hide in the scalp. But a large review of published data suggests that our fears may be overblown, with no increase in the already low incidence of scalp metastases linked to use of cooling devices. I look forward to the results of this confirmatory trial.