FDA Approves Trial to Test New Treatment for chemotherapy-related hair loss
WINSTON-SALEM, N.C. - JULY, 2013 - Wake Forest Baptist Medical Center will conduct a second clinical trial of the DigniCap® System, a scalp-cooling technology that helps prevent chemotherapy-related hair loss.
The U.S. Food and Drug Administration (FDA) recently gave Dignitana, the parent company, approval for its Investigational Device Exemption (IDE) application which allows for a multi-center clinical trial of the patented DigniCap® System. The trial is the second and final phase of study in the United States and paves the way for FDA market approval of the scalp-cooling device, which is already widely used overseas.
Besides Wake Forest Baptist, clinical trials will be conducted with 110 patients at major medical centers across the country including University of California San Francisco. Additional centers in New York City will be announced this summer.
"Wake Forest Baptist is excited to be a part of the upcoming trial to further test the DigniCap for breast cancer patients," said Susan A. Melin, M.D., associate professor of hematology and oncology. "Being able to safely prevent chemotherapy-induced hair loss may relieve patients of some of the emotional stress they are already going through."
To participate in the trial patients must be 18 years of age and have a documented diagnosis of stage I or II breast cancer, and must plan to complete chemotherapy within six months using standard chemotherapy regimens stipulated in the trial protocol.
High Point, N.C., resident Cheryl Cook was able to successfully participate in the 2011 feasibility study conducted by Wake Forest Baptist. With a breast cancer diagnosis of stage one with no node involvement, she was facing chemotherapy and hair loss.
"I have always been a very upbeat person, and decided immediately that this diagnosis was not going to rob me of my joy," she said. "I will be forever grateful for the opportunity to be a part of the DigniCap Study. It made such a difference in how I dealt with my cancer."
The state-of-the-art DigniCap® System being tested in this study 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. Both are connected to a cooling and control unit with touch screen controls. A patented coolant circulates throughout the inner silicone layer, and the cap is designed to deliver consistent cooling to all areas of the scalp. DigniCap is the only system to offer scalp-cooling above freezing with patented, built-in temperature sensors and a precision cooling mechanism that allows for gradual and highly tolerable scalp temperature fluctuations.
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.
Clinical trials done in Europe and Asia show eight out of 10 women who used the DigniCap® System during chemotherapy retained their hair. Additional trials at leading medical centers around the world have proven the system to be a viable alternative for both women and men of diverse ethnicities.
Historically, 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. UCSF's Principal Investigator Hope S. Rugo, M.D. reports that "the incidence of scalp metastases in breast cancer is extremely low and we are carefully following patients using these systems."