She and her research colleagues across the country have begun a clinical trial on a new device that may reduce or prevent the hair loss of patients receiving chemotherapy for breast cancer.
Hurvitz and colleagues are testing an apparatus called the DigniCap® System, that works by gradually cooling the patient’s scalp to just above freezing while they are receiving chemotherapy drugs.
In addition to running clinical trials conducted at UCLA’s Jonsson Comprehensive Cancer Center, they are also recruiting for trials at the University of California, San Francisco Helen Diller Family Comprehensive Cancer Center, Weill Cornell Breast Center and Beth Israel Medical Center’s Comprehensive Cancer Center, both in New York City, and the Wake Forest University School of Medicine in Winston-Salem, NC.
When the temperature of the scalp is lowered, the blood vessels around the roots of the hair contract, or grow smaller. That cap’s contraction reduces the blood flow to the hair follicles, so less of the drug can reach them.
“Normally the drug would damage the follicles and make the hair fall out. The reduced blood flow from the scalp cooling reduces the amount of drug that reaches the follicle, thus reducing or eliminating damage to the hair follicle and preserving the patient’s hair,” Hurvitz said.
Trial data from Europe and Asia has shown promising results. “Eight of ten women who used this system were able to retain their hair during breast cancer chemotherapy,” she said, “and now that the FDA has approved it for trials in the United States we have high hopes for helping patients deal with the mental and emotional strain that comes with our treatment of their breast cancer.”
Researchers hope to enroll 110 participants within the next few months under the FDA premarket approval process. Since the trial is non-randomized, all participants wanting to use the DigniCap® System will be able to do so, Hurvitz said.