DigniCap, a scalp-cooling device that reduces hair loss during chemotherapy for breast cancer patients by reducing blood flow to the scalp and decreasing the activity of the hair follicles, has been approved by the FDA for market in the U.S.
A common side effect of chemotherapy for the treatment of breast cancer is hair loss. With recent FDA approval, a Swedish company, Dignitana Inc., is hoping that the DigniCap Intelligent Scalp Cooling System will help breast cancer patients minimize hair loss during treatment and improve their quality of life.
DigniCap is a silicone-based cap with channels of circulating coolant that the patient can wear during treatment to cool their scalp. It has multiple sensors in the cap to maintain a consistent temperature and is connected to a computer-operated controlling unit. A lower scalp temperature reduces the blood flow to the scalp and decreases the cell division activities of the hair follicle, making it more resistant to chemotherapy and less likely to fall out.
A patient would typically start using DigniCap to gradually cool the scalp 30 minutes prior to chemotherapy, continue to use it during treatment, and up to 150 minutes post-therapy depending on their individual chemotherapy treatment. Although the temperature of the device does not drop below zero degrees, common side effects that have been reported are a feeling of coldness, headache, light-headedness, and some pain.
The clinical trial that supported FDA clearance reported that DigniCap prevented hair loss in approximately 70% of patients treated for breast cancer by adjuvant therapy versus controls who did not use DigniCap and experienced significant hair loss. While DigniCap has just been approved for use in the U.S., it has been used in other countries for more than 10 years by patients treated for breast cancer with taxane and anthracycline chemotherapies.
With FDA approval, Dignitana Inc. will be finalizing agreements with major cancer treatment centres across the U.S, making DigniCap treatment available to patients hopefully by early next year.
FDA press release: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm476216.htm
DigniCap website: http://www.dignicap.com/
Written by Fiona Wong, PhD