Kelly Young, Edited by Susan Sadoughi, MD

The FDA has cleared the DigniCap scalp cooling system for marketing, according to an announcement from the manufacturer. The cap aims to reduce chemotherapy-induced hair loss among women with breast cancer.

In a trial of over 100 women receiving chemotherapy (mostly taxanes) for stage 1 or 2 breast cancer, just 34% of patients who underwent scalp cooling lost over half of their hair, compared with 100% in the control group. There were no serious adverse events, although three patients discontinued use because of the cold sensation, which does not dip below 32 degrees F (0 degrees C).

During treatment, patients wear a tight-fitting silicone cap through which coolant circulates. When the scalp temperature is lowered, blood vessels constrict, which leads to less chemotherapy being delivered to the area. In addition, the intra-follicular metabolic rate is reduced, leading to less uptake of the chemotherapy drugs, according to the manufacturer.