SYDNEY, AUSTRALIA — A silicone cap that helps stop hair loss in cancer patients undergoing chemotherapy is gaining a foothold in Australia, with caps being used in three hospitals.
The DigniCap scalp-cooling system, developed by Dignitana AB, based in Lund, Sweden, is not yet approved for use in the United States, but is used in Australia, Canada, China, the European Union, Singapore, Colombia, South Korea, Mexico and Russia, according to Dignitana Swedish area manager Ivar van der Linden.
The cap is being evaluated in Japan, India, Hong Kong, Chile, Saudi Arabia and Turkey.
The cap and cooling system were developed in the mid-1990s after a Swedish oncology nurse suggested heat generated by chemotherapy is the primary factor in cancer patients' hair loss.
Van der Linden hopes full U.S. approval will be granted soon. Dignitana has pre-market approval from the Food and Drug Administration, but is awaiting approval for the cap to be used for cancer treatment.
“FDA approval is important so [the cap] can be made more widely available to patients in the U.S.,” van der Linden said. “A pivotal clinical trial that is currently underway is just one part of the FDA pre-market approval process that has been on-going in the U.S. since 2010.”
Some 110 cancer patients in California, North Carolina and New York hospitals have been participating in the clinical trial and FDA evaluation since 2013.
Dignitana's Australian distributor Anika Burkhardt said the DigniCap is popular in Australia and there are plans to expand its use to more hospitals. She said Australian nurses have reported female patients in particular are relieved they can be treated for cancer without the fear of going bald.
The cap is manufactured from standard-grade silicone and has an inbuilt cooling system that keeps a wearer's scalp at a consistent temperature while chemotherapy treatment is in progress. Cooling the scalp helps reduce damage to hair follicles and subsequent hair loss.
The cap, attached to a refrigeration unit, is put on a patient's head at room temperature. Sensors within the cap register body temperature variations and automatically adjust the cap's cooling capacity to provide an even temperature to the hair follicles.
