The FDA has given approval for an investigational device exemption (IDE) feasibility study to be conducted at both Wake Forest Baptist and University of California, San Francisco (UCSF). A total of 20 patients with stage one breast cancer will be involved – 10 at Wake Forest Baptist and 10 at UCSF. The study will test the safety and tolerability of the patented DigniCap™ scalp cooling system which is worn by patients during chemotherapy treatment to prevent hair loss. The IDE feasibility study is the first step required to gain FDA approval.
The scalp cooling device is already in clinical use throughout Europe, Canada and Japan.
Susan Melin, M.D., principal investigator for the study, said data from several large international studies involving almost 1,000 chemotherapy patients indicate the device is safe to use and does prevent hair loss. Melin is an associate professor of Internal Medicine-Hematology and Oncology at Wake Forest Baptist who specializes in breast cancer.
“One of the first questions my patients ask is whether they will lose their hair with the chemotherapy recommended for their breast cancer,” Melin said. “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.”
The DigniCap™ system, developed by the Swedish company Dignitana, features a tight-fitting silicone cap that is 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. A coolant circulates throughout the inner silicone layer, and the cap is designed to deliver consistent cooling to all areas of the scalp. The device features safety sensors that continuously monitor and optimize the treatment temperature.
When a cap is applied to the head, the temperature of the scalp is lowered and 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, and the decreased temperature results in less absorption of and reduced effects from chemotherapy. These factors together reduce the risk of hair loss.
Melin said that a larger efficacy study would include patients with stage one or stage two breast cancer. “Basically, the Dignicap would be used for certain patients who have a moderate chance of their cancer recurring,” she said.
The DigniCap™ system was invented and commercially launched early 2001 and the patented innovation is by Swedish oncology nurse Yvonne Olofsson, who was moved to help her patients cope with the emotionally traumatic condition of hair loss following cytotoxic therapy for cancer.