FDA clears cold cap to save hair
WASHINGTON — Hair loss is one of the most despised side effects of chemotherapy, and now breast cancer patients are getting a new way to try to save their locks.
The Food and Drug Administration said Tuesday it would allow marketing of the DigniCap, a cooling system that chills patients’ scalps to reduce the hair loss that is so common during breast cancer treatment.
A doctor who led research with the hair-preserving strategy welcomed the FDA’s move, saying hair loss has a traumatic effect on patients, and survivors, by revealing an illness that many would prefer to keep private.
“It’s such a marker for women — for work, for their families, for their children — that something’s wrong with them,” said Dr. Hope Rugo of the University of California, San Francisco. “You get just a few months of chemotherapy, and it takes more than a year for your hair to recover.”
Scalp cooling is an idea that’s been around for decades. The near-freezing temperatures are supposed to make it harder for cancer-fighting drugs to reach and harm hair follicles by temporarily reducing blood flow and cell metabolism in the scalp.
Several versions of cold caps are sold around the world. In the U.S., breast cancer patients sometimes bring collections of gel-filled caps to chemo sessions in ice chests, or store them in hospital-provided freezers, so that when one cap thaws they can don another.
But the DigniCap, made by Sweden’s Dignitana AB, is the first version officially cleared by the FDA. The company will lease the device to cancer centers to use as their patients come in for chemotherapy.
Rugo and oncologists at four other medical centers studied the DigniCap system in 122 women undergoing standard chemo regimens for early-stage breast cancer. More than two-thirds of the treated women kept more than half their hair.
“Looking healthy made me feel healthier,” said Deanna King of San Francisco, who participated in the trial in late 2013 and said she retained 80 percent of her hair.
She’d been between jobs when she was diagnosed with breast cancer, and keeping her hair made it easier to restart interviews with potential employers.
“People are frightened of people that look sick,” King said. “It made the experience a little less traumatic.”
The most common side effects of the DigniCap treatment were cold-induced headaches and neck and shoulder discomfort, chills and pain associated with wearing the cooling cap for an extended period, the FDA said.
