For the first few days after her breast cancer diagnosis last summer, Heather Millar kept it together.
But when the 47-year-old San Francisco woman finally cried, the tears fell, in part, at the thought of losing her hair.
“That’s a world you never hope to be a part of,” said Millar, a freelance writer and mother of a 9-year-old daughter. “The hair, it’s not the most important thing, but it’s such a stigma of cancer. The minute you’re wearing a scarf or something, it makes social interactions weird.”
Three chemotherapy sessions later, Millar has managed to avoid the fate that affects at least 65 percent of cancer patients dosed with the powerful drugs that target disease. Many start shedding their hair after just one treatment.
She still has most of her shoulder-length, dark blond locks, thanks to an experimental treatment that uses extreme cold to prevent cancer patients from losing their hair. Millar is one of just four patients in the U.S. so far to try the “DigniCap,” a tightly fitting hat equipped with a circulating cooling gel that chills hair follicles to limit the amount of chemotherapy they absorb.
Eventually, she may be part of a 100-person pivotal trial required by the federal Food and Drug Administration to test the Swedish device for safety and effectiveness.
For now, she’s showing up every few weeks at the University of California, San Francisco’s cancer center to get better — and to help other patients beat what’s easily the most dreaded side effect of chemotherapy treatment.
“I think that if women knew about this, there would be a total stampede,” says Millar, who has chronicled her experience in a blog, My Left Breast.
No hair? No chemo, some say
For some women, the fear of losing their hair prompts them to forgo chemotherapy treatment entirely, while others delay therapy or choose less-effective care, said Dr. Hope S. Rugo, director of breast oncology and clinical trials education at the UCSF Helen Diller Family Comprehensive Cancer Center.
Even though the hair grows back later, it can be emotionally and psychologically devastating.
“It’s torture for the women,” Rugo said. “Patients will say to me, ‘I know this sounds stupid, it seems so much like my vanity, but the thing I’m most worried about is losing my hair.’”
One late-stage cancer patient who’d already been through a bout of chemotherapy-induced alopecia, the technical term for the hair loss, couldn’t take it again.
“She said ‘I’d rather die now than live an extra year without my hair,’” said Rugo.
UCSF is one of two U.S. sites testing the DigniCap, which is manufactured by the firm Dignitana in Lund, Sweden. Wake Forest University Baptist Medical Center will begin enrolling patients next month, said Dr. Susan A. Melin, an associate professor of hematology and oncology in the school's Comprehensive Cancer Center.
The trial is limited to women with early-stage breast cancer who require chemotherapy, but the scalp-chilling technique has been used successfully for other kinds of cancer and in men who don’t want to lose their hair, advocates say.
Rugo, of UCSF, agreed to participate in the new trial in part because she’s been supervising scalp-freezing techniques to stop hair loss for three years, ever since a patient proud of her long, blond curly hair simply refused to let it go.
Instead, the patient convinced Rugo to let her try the Penguin Cold Cap, a British-made product used widely in Europe and now making inroads with cancer patients in the U.S.
The strap-on hats are filled with gel cooled to -30 Celsius that must be kept cold in special freezers or with dry ice, according to the company’s website. Patients must change the caps every 20 to 30 minutes before, during and after chemotherapy treatments, sometimes using as many as 15 caps per session to maintain proper scalp temperature.
It’s a technique that saved Shirley Billigmeier’s luxuriant brown hair after she was diagnosed with breast cancer in 2009 and balked at wearing a wig.
“No matter how good a wig it is, it just was not me,” said Billigmeier, 60, of Orono, Minn. “People think it’s a vanity thing, but it’s not just that. I’m not a victim-type person. I didn’t want to be labeled as sick and a victim. This was a protection for what I already had.”
Ice cubes in plastic bags
The idea that freezing the scalp could help preserve hair during chemotherapy has been around since the 1970s, when patients strapped bags of ice cubes to their heads.
Cooling the scalp dramatically causes the blood vessels surrounding hair roots to contract, reducing the amount of chemotherapy drugs delivered to the follicle, Rugo said.
Early trials of several devices resulted in problems such as scalp frostbite or hair that fell out in patterns that matched the coils on a cap.
Freezing devices including the cold caps and the DigniCaps, as well as products by two other makers, are used throughout Europe, Scandinavia, Japan and other countries, though none has been approved by the FDA in the U.S. FDA officials declined to comment on the feasibility study being conducted by Dignitana.
Historically, the caps have not been used in the U.S. because of worries that cancer cells might lurk in the scalp, where the cold would prevent chemotherapy from killing them.
So far, studies indicate that the risk of scalp metastases is very low, said Rugo. She cited results from two large studies of 1,440 patients followed for five to nine years, which found only 10 patients developed scalp cancers.
Still, some cancer specialists remain unconvinced about the benefits and wary of the risks of scalp hypothermia, as the procedure is known. Marlon Garzo Saria, a clinical nurse specialist and spokesman for the Oncology Nursing Society, said he does not recommend the treatment in his work in the Division of Neuro-Oncology at the Moores Cancer Center at the University of California, San Diego.
"There is a concern that it prevents chemotherapy from reaching cancer cells that may be present in sanctuary sites in the brain," Saria said by e-mail. "Until we can find clear evidence that this is not so, I would rather err on the side of caution and presume that the risk of cancer recurrence outweighs the benefit of preventing hair loss in patients receiving chemotherapy."
Up to 100 percent effective
Patients and experts who pursue the technique, however, say the benefits can be profound. Most patients still lose some hair, but it might be 15 percent to 25 percent of their hair, at most, compared to all of it, Rugo said. Studies have shown that the effectiveness can range widely, from 45 percent of patients to 100 percent of patients not requiring a wig or hat, though that depends on the person and the kind of treatment they require. She estimates that about 60 percent of patients preserve most of their hair.
Being able to keep most of her hair is a blessing, but the procedure isn’t exactly pleasant, said Millar, the DigniCap patient. The mechanical cap comes with several layers, including a head-gripping hat that gradually chills to 5 degrees Celsius — 41 degrees Fahrenheit. It’s pulled tightly over completely wet hair, the better to conduct the near-freezing temperatures.
“The cold is pretty intense,” Millar said. “When it starts not to feel good is about 10 degrees Celsius.”
Some patients get bad headaches worse than the brain-freeze caused by eating ice cream too fast. Others feel claustrophobic in the caps that Millar likens to cold Medusa-like snakes coiled around her head.
But patients like Shirley Billigmeier say once their heads were numb, they no longer noticed the cold.
“It’s like three or four minutes,” for each cap, she said. "After that you don’t feel a thing.”
Both women said they've had to baby their hair during chemotherapy treatment: No blow dryers, less-frequent shampoos, gentle brushing. The upside was that at least there was hair to brush.
The biggest drawback to scalp-chilling is that so few cancer patients know enough about it to consider it as an option, patients and doctors said. Billigmeier and a friend, Nancy Marshall, started a nonprofit group, The Rapunzel Project, to raise awareness of the issue.
If a devices eventually are approved by the FDA, the technique could be revolutionary for the 225,000 women diagnosed with breast and ovarian cancer in the U.S. each year, Rugo said.
“For most women, I think this would be an incredible thing,” she said. “For young women and old women, it doesn’t make a difference in age, it’s a huge issue.”