Wake Forest Baptist Medical Center is the first medical center in the United States to offer the FDA-cleared DigniCap scalp cooling system to patients undergoing chemotherapy for breast cancer.
In clinical
trials of the system, seven out of 10 patients with early stage breast cancer
kept at least 50 percent of their hair.
No severe adverse effects were reported.
Wake Forest Baptist conducted the initial feasibility study in 2010 with the University of California San Francisco, and then went on to participate as one of the five sites conducting the FDA trial.
“We
are very pleased to be the first to offer the DigniCap system in the U.S. We have been heavily involved in the clinical
trials and I know that the system will be appreciated by our patients,” said Susan
Melin, M.D., associate professor of hematology and oncology and principal
investigator of the clinical trials at Wake Forest Baptist.
Although the cooling system has been available across Europe and in Asia and Australia for several years, it wasn’t FDA-cleared for use in the United States until Dec. 8, 2015.
The scalp cooling system features a patented
tight-fitting silicone cooling cap that is placed directly on the head, and an
outer neoprene cap that insulates and secures the silicone cap. The cooling cap
is connected to a cooling and control unit with touch screen prompts. A liquid
coolant circulates throughout the silicone cap, delivering consistent and
controlled cooling to all areas of the scalp.
The cap is fitted to the head, and the temperature of the scalp is lowered, resulting in a constriction of the blood vessels with reduced delivery of chemotherapy to the scalp, as well as reduced uptake of the chemotherapy drugs in the scalp. These factors together reduce the risk of hair loss.
Because
it is considered an elective treatment, the DigniCap may not be covered by
medical insurance; women should contact their insurance provider.
The DigniCap scalp cooling system is manufactured by Dignitana, a Swedish public company based in Lund.
Media Relations
Mac Ingraham: mingraha@wakehealth.edu, 336-716-3487
Joe McCloskey: jmcclosk@wakehealth.edu, 336-716-1273