A system called DigniCap from Dignitana (Lund, Sweden) has just been FDA cleared for final clinical trials and may soon become available in the U.S. to help prevent chemo related hair loss. DigniCap consists of a touch screen equipped refrigeration and control unit that monitors scalp temperature and delivers cooling liquid to the inner cap. The inner cap is a silicone device that fits snuggly on the head and contains sensors and channels through which a cooling fluid is pumped. The channel network is separated into two parts so that the front and back of the head can be cooled independently. Finally, an outer cap keeps the system insulated and absorbs water that condenses on the cooling inner cap. Dignitana had success in international clinical trials of its device and expects that the DigniCap will soon receive regulatory approval in the U.S. The current FDA approved trial will involve people with stage I or stage II breast cancer who will undergo standard chemotherapy treatment.
According to the company, clinical trials done in Europe and Asia show that eight out of ten 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 Hope Rugo reports that “the incidence of scalp metastases in breast cancer is extremely low and in a large review of published data on scalp cooling systems, scalp metastases were not increased. We are carefully following patients using these systems in several clinical trials.”
REFERENCE: Med Gadget; Jun 7, 2013