Hope S. Rugo, MD, director of Breast Oncology and Clinical Trials Education, UCSF Helen Diller Family Comprehensive Cancer Center, discusses the DigniCap cooling system to reduce the severity and frequency of hair loss in patients receiving chemotherapy for breast cancer.
The system became the nation's first FDA-approved cooling cap in December 2015.
Rugo and fellow researchers initially partnered with the manufacturer, Dignitana, to test the device on 20 patients with stage I breast cancer. The study found that the caps were effective and well-tolerated.
Rugo then conducted a pivotal trial with more than 100 patients from five different institutions who had stage I/II breast cancer. The results showed that nearly 70% of the women lost less than half of their hair.