Mount Sinai Health System Launches DigniCap Scalp Cooling System for Women with Breast Cancer
The Mount Sinai Health System (MSHS) announced the launch of the DigniCap® scalp cooling system, which was recently cleared by the U.S. Food and Drug Administration (FDA) to reduce the likelihood of chemotherapy-induced hair loss in women with breast cancer, in three of its cancer center locations. Mount Sinai is also the first and only health system in New York to currently offer breast cancer patients the Dignicap, which is now available at the Dubin Breast Center of The Tisch Cancer Institute, Mount Sinai Downtown-Chelsea, and Mount Sinai West. In the FDA clinical trials completed in the United States, 7 out of 10 patients with early-stage breast cancer kept at least 50 percent of their hair.
“We are extremely excited to be able to offer patients the Dignicap scalp cooling system during chemotherapy, which allows them to retain normalcy and privacy in their lives,” said Paula Klein, MD, Associate Professor of Oncology and Hematology at the Icahn School of Medicine at Mount Sinai, who studied the Dignicap system as part of a multi-center clinical trial which eventually led to FDA clearance in December 2015. “Losing hair is one of the more distressing side effects of chemotherapy, and this is a game changer for so many patients.”
The DigniCap scalp cooling system, made by the Swedish company Dignitana AB, with U.S. headquarters in Dallas, Texas, 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 vasoconstriction with reduced delivery of chemotherapy to the scalp, as well as reduced cellular uptake of drugs due to decreased intrafollicular metabolic rate. These factors together reduce the risk of chemotherapy-induced hair loss.
“Time and time again, I have heard so many of my female patients with breast cancer tell me that hair loss was the worst part of their chemotherapy,” said Charles Shapiro, MD, Director of Translational Breast Cancer and Research, and Director of Cancer Survivorship at The Tisch Cancer Institute. “But now there is a treatment to mitigate this side effect and help to improve a patient’s experience during a very difficult time in their life.”
"Mount Sinai was an important partner for Dignitana as we clinically tested the DigniCap system to ensure safety and efficacy," said Bill Cronin, CEO of Dignitana, Inc. "To be able now to offer women throughout the entire Mount Sinai system an alternative to chemotherapy-induced hair loss is a major step forward in our vision to make what for many is an emotionally traumatic side effect, a thing of the past."
About the Mount Sinai Health System
The Mount Sinai Health System is New York City's largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai is a national and international source of unrivaled education, translational research and discovery, and collaborative clinical leadership ensuring that we deliver the highest quality care—from prevention to treatment of the most serious and complex human diseases. The Health System includes more than 7,200 physicians and features a robust and continually expanding network of multispecialty services, including more than 400 ambulatory practice locations throughout the five boroughs of New York City, Westchester, and Long Island. The Mount Sinai Hospital is ranked No. 14 on U.S. News & World Report's "Honor Roll" of the Top 20 Best Hospitals in the country and the Icahn School of Medicine as one of the Top 20 Best Medical Schools in country. Mount Sinai Health System hospitals are consistently ranked regionally by specialty and our physicians in the top 1% of all physicians nationally by U.S. News & World Report.