UCSF physicians evlaute devices that could reduce hair loss in breast cancer patients undergoing chemotherapy
December 10, 2015
Historically, Rugo said, cooling systems and cold caps have not been used in the United States because of concerns that the scalp cooling could allow cancer cells to hide in the scalp. But, Rugo said, "the incidence of scalp metastases in breast cancer is extremely low and we are carefully following patients using these systems."
The goal of the new feasibility study - the first step toward FDA product approval - is to test how well patients tolerate the device, invented in the 1990s by a Swedish oncology nurse.
In the study, a tight-fitting silicone cap is placed directly on the head; an outer neoprene cap is placed on top to insulate and secure the inner cap. Both are connected to a cooling and control unit with touch screen controls. A coolant circulates throughout the inner silicone layer, delivering consistent cooling to the entire scalp.
Following the feasibility study of 20 patients, a larger study of 100 patients is planned, an example of UCSF's commitment toward accelerating the translation of cutting-edge research into advances in patient care.
According to research by Dignitana, makers of the DigniCap system, 8 out of 10 women in Europe and Asia who used the company's cap cooling system during chemotherapy retained their hair.
"The DigniCap system has been extremely well received in clinical trials at leading medical centers around the world," said Chief Executive Officer Martin Waleij. "We are very pleased that UCSF is conducting this test so that cancer patients in the United States might benefit as well."
Source: University of California - San Francisco