For many women, the most traumatic aspect of chemotherapy treatment for cancer is the prospect of losing their hair.
“Waking up to a pillow covered with hair is the first outward sign that they really are sick, that they really might die,” said Dr. Virginia Kaklamani, an oncologist at the Cancer Therapy and Research Center in San Antonio. “It can be very upsetting.”
On Friday at the CTRC, Kaklamani’s patient Adrianne Frost was the first breast cancer patient in the United States to wear a medical device designed to help prevent such hair loss.
Approved by the Food and Drug Administration in December, the DigniCap Cooling System circulates an antifreeze-like coolant through channels in a silicone skull cap. The cap is worn before, during and for 30 minutes or more after a chemo session.
Lowering the scalp temperature constricts blood vessels in the area and helps prevent harsh chemotherapy drugs from destroying hair follicles, which typically results in hair loss.
Studies have found that up to 6 percent of women with cancer will refuse chemotherapy because they don’t want to lose their hair.
“When you lose your hair as a cancer patient, you lose your anonymity,” said Frost, 43, whose breast cancer was diagnosed in November. “You go out in public and, even if you’re wearing a hat or a pretty scarf, people know that ‘there goes a cancer patient.’”
Kaklamani noted that men tend not to be as concerned as women about losing their hair, especially since they’re typically older when they’re diagnosed with cancer.
“So they already have some experience with hair loss,” she explained with a wry grin.
Made by Swedish company Dignitana, the DigniCap is essentially a sophisticated air-conditioning system for the head. The R2D2-sized main unit chills the monopropylene glycol coolant to 37 to 41 degrees and pumps it through tubes to the skullcap, which has channels through which the coolant circulates.
A neoprene covering worn over the cooling cap insulates it and keeps it in place.
“I told her she looks like a Russian cosmonaut,” Frost’s husband, Tom Kelly, said Friday as the clinical support manager from Dignitana adjusted the cap over her long, dark hair.
Once the coolant starts circulating, sensors in the cap adjust the flow to keep the patient’s head within the optimum temperature range to help prevent hair loss — but not so cold as to be truly uncomfortable or risk skin damage.
Later in the afternoon, as she was finishing her treatment, Frost described the experience: “For the first 10 minutes it felt good. But then it got really, really cold and for about five minutes I had sort of a brain freeze. But ever since then, I’ve been fine. It’s like I got numb to it, and it hasn’t bothered me a bit. It’s quite comfortable actually.”
In trials, 70 percent of women who underwent the hair-saving treatment said they did not feel the need to wear a hat, scarf or other head covering while out in public.
“They may have still lost some hair, but not enough to make them truly uncomfortable,” said Bill Cronin, chief operating officer at Dignitana.
In addition to saving hair, the DigniCap should also increase awareness of cold cap therapy, according to Nancy Marshall, co-founder of The Rapunzel Project, a Minnesota nonprofit that creates awareness of the existence and effectiveness of the treatment.
“Just yesterday, I received five emails from clinics that weren’t aware this option even existed,” she said. “With DigniCap getting FDA approval, it will be a new era for the technology.”
At present, the hair-saving device has been approved only for women with breast cancer. New clinical trials are in the works to extend that approval, but until then, physicians can prescribe it “off label” to patients with other types of cancer.
Scalp cooling to prevent hair loss dates back at least to the 1970s. But until the DigniCap was introduced, patients had to rely on what are known as cold caps, head coverings that are chilled either in a freezer or with dry ice and worn like a swim cap.
But these caps must be changed every 30 minutes or so, and there must be a way to re-freeze them if necessary while the chemo treatment is administered. There’s also a risk of frostbite if the cap is too cold.
“It’s really labor intensive,” said Frost, who researched her hair-saving options prior to undergoing chemo.
While preventing hair loss isn’t a matter of life and death, Kaklamani noted that cancer patients who retain a positive attitude tend to have better outcomes than those who are depressed or overly pessimistic.
Because the device was only recently approved, the cost to patients is still being determined. Plans call for patients to be charged per infusion, and news reports estimate the total cost could range from $1,500 to $3,000 depending on the patient’s course of treatment.
It’s also unknown whether insurance will cover the treatment (cold cap treatment typically is not covered) although FDA approval does increase the likelihood. For patients who may not be able to afford the treatment, Adrianne Frost is in preliminary discussions about setting up a nonprofit to raise funds to subsidize the cost.
“We’ve just started looking into it,” said Frost, who is a member of the Frost banking family. (She is the daughter of Tom Frost III.) “But we do have a name: Keep It Cool.”