For many women facing the emotional and physical whirlwind of breast cancer treatment, the possibility of losing their hair is one more trauma to go through.“It’s typically two of the first questions I get: ‘Will I lose it, and when will I lose it?’” said Dr. Susan Melin, who specializes in treating breast cancer as an associate professor of internal medicine—hematology and oncology—at Wake Forest Baptist University Medical Center.
“They feel like it is a declaration to the world of their condition and the chemotherapy that they’re about to go through.”
Melin is hopeful that a feasibility study of a scalp-cooling device—just under way at Wake Forest Baptist—will enable her to eventually answer “no” more often to those questions.
“Preventing chemotherapy-induced hair loss by using the scalp-cooling cap may relieve severe psychological and emotional stress and improve the patient’s quality of life,” Melin said.
The Food and Drug Administration has approved Wake Forest Baptist and the University of California at San Francisco for an investigational device exemption for DigniCap, which is made by Dignitana of Lund, Sweden. The study is the first step required to gain FDA approval. Melin is the principal investigator for the Wake Forest Baptist study.
The device, aimed at patients with stage 1 breast cancer, is already in clinical use in Canada, Europe, and Japan. According to the Dignitana website, more than 80 percent of the patients have kept their hair during chemotherapy.
Both US medical centers will enroll 10 patients. The first patient at Wake Forest Baptist is set to undergo chemo treatment while wearing the cap. UCSF has at least five patients enrolled.
The device is a tight-fitting silicone cap placed directly on the head, and an outer neoprene cap that insulates and secures the inner one. The cap is connected to a cooling and control unit with touch-screen controls. The design leaves the ears uncovered.
A coolant circulates throughout the inner silicone layer. The cap is designed to deliver consistent cooling to all areas of the scalp. The device features safety sensors that monitor and optimize the treatment temperature, typically around 42 degrees. A lower temperature is recommended for patients with thick hair.
When a cap is applied to the head, the temperature of the scalp is lowered over a 20- to 30-minute period. Blood vessels surrounding the hair roots contract, resulting in a significant reduction of cytotoxins to the follicle.
Reduced blood flow leaves a smaller amount of chemotherapy available for uptake in the cells. The decreased temperature results in less absorption of—and reduced effects from—the chemotherapy.
The treatment cycle, depending on the patient, would range from four times over a two-month period to eight times over a four-month period, Melin shares.
Melin said there have been few side effects with the cap, primarily headaches. Melin said that one of the goals with the study is to determine if it is safe and will cause no side effects.
Patients will have follow-up visits of three, six, nine and twelve months to determine whether hair has grown back.
Melin said that a larger efficacy study would include patients with stage 1 and stage 2 breast cancer. “Basically, the DigniCap would be used for certain patients who have a moderate chance of their cancer recurring,” she said.
