A handful of San Francisco breast cancer patients are donning frigid skullcaps to test a device designed to keep hair tightly rooted during chemotherapy.
Researchers hope the study, run by UC San Francisco and Wake Forest University in Winston-Salem, N.C., will eventually lead to Food and Drug Administration approval for the chilly caps.
There is now no way to hang on to one's tresses during chemo for any kind of cancer, says study leader Hope Rugo, an oncologist at UCSF. The prospect of baldness is distressing to many patients, particularly women. Some choose a less-drastic drug regimen more likely to leave hair follicles alone, potentially at the cost of getting the best possible treatment. It's a fact that women frequently make treatment decisions based on risk to their locks, says Rugo's colleague Michelle Melisko, another oncologist investigating scalp-cooling systems.
The caps' low temperature, 41 degrees Fahrenheit, keeps poisonous chemotherapy drugs out of the hair follicles. But some doctors worry that in so doing, it makes it more likely that cancer will take root in the scalp.
More than 4,000 people have used one device, the DigniCap, made by Dignitana in Lund, Sweden, and more than 85% of those reported keeping their hair, says Dignitana Chief Executive Martin Waleij. Rugo is examining the DigniCap; Melisko is conducting a separate study on a different system, called the Penguin cap.
Chemotherapy works by attacking cells that are rapidly growing and reproducing. That includes cancer cells but also fast-growing tissues such as the stomach lining and hair follicles.
The DigniCap cycles coolant through channels in a snug silicone helmet, which is attached to a rolling control unit. Patients don the cap 20 minutes or so before chemo, then wear it throughout the procedure and for half an hour or longer afterward. In the chilled-down scalp, blood flows sluggishly, limiting delivery of chemo to the follicles. The cold also slows the metabolism of hair follicles, so they process less of the chemo they do receive.
The study is starting with 20 early-stage breast cancer patients, simply to see if the system is feasible, with a goal of at least half of the women sticking with the caps. If successful, then the researchers plan a 100-person trial. If all goes well, Waleij hopes to gain FDA approval by late 2012.
The concept of cooling to prevent hair loss has been around since the 1970s. A 2005 review published in the Annals of Oncology found that the results from 53 studies using various devices and methods were mostly positive.
However, most users will lose at least some hair, and the system does not work for all. For example, a person on a two- to three-month treatment plan has a better chance of keeping her hair with scalp cooling than someone getting six months of chemo.
The specific drugs used also make a difference. Scalp cooling is effective with either anthracyclines or taxanes, for example, but not when the two are used in combination.
Though the UCSF studies are focusing on breast cancer, people with other types of cancer could benefit too. However, doctors would not use the cap for cancers such as leukemia or lymphoma, because those cancer cells, instead of concentrating in an organ such as the breast, circulate in blood vessels beneath the scalp.
Even with breast cancer, there are safety concerns, because the cancer occasionally spreads to the scalp. "My objection is a concern that we're letting a part of the body not see chemotherapy," says Dr. Christy Russell, co-director of the Norris Breast Center at USC and a member of the American Cancer Society's national board of directors. Russell also doubts many cancer centers would spare the time and space to include DigniCap treatment on top of regular chemo.
Breast cancer spreading, or metastasizing, to the scalp is "a very rare phenomenon," Melisko says. She and Rugo have conducted a review of the literature, which Melisko presented at the San Antonio Breast Cancer Symposium earlier this month. They found that in multiple published studies with hundreds of breast cancer patients, incidence of scalp cancer in those patients ranged from zero to 2.5%. And in half a dozen studies of scalp cooling that the researchers reviewed, fewer than 2% of patients had scalp metastases. "It's not really something that we should be worried about," Melisko says.
For some, the benefits outweigh the potential risk. "It's not just vanity," says Heather Millar, a magazine writer who has gone under the UCSF-tested DigniCap three times during chemotherapy for breast cancer and says balding is the most noticeable badge of the disease. "If you're running around with a scarf on your head, everybody knows you have cancer," Millar says. "You want to be able to choose who you're going to share it with."
Hair loss also represents one more thing cancer rips away from a woman, Millar says, adding to a long list that includes health and body parts, the ability to work or the ability to have children. And seeing Mom's hair fall out is frightening for kids, she adds.
With the DigniCap, Millar estimates she still has 90% of her hair. But she says the procedure is unpleasant. The cold can cause a brain-freeze-type headache or irritate the skin. "The first time, I burst into tears" as the temperature neared 50 degrees, she says. But once the scalp numbs from the cold, it feels better.
The other device under study, the polyurethane Penguin cap made by London-based Medical Specialties of California, is available for mail-order rent. The gel-filled caps quickly warm once put on, so users must keep them in a supercooled freezer and will need several in a single session. Melisko is tracking satisfaction and side effects in women who use the Penguin system, which she estimates costs about $600 to rent for a course of chemo plus the expense of the special cooler. .