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.
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