It's no surprise that most women with breast cancer consider hair loss one of the most traumatic aspects of chemotherapy. That has led to a big market for cooling caps, which are purported to limit hair loss.
But cooling caps haven't been extensively studied in the U.S., and womens' experiences with the caps have been hit or miss. And just one cooling cap, the DigniCap, is approved by the Food and Drug Administration.
Two studies released Tuesday show that at least half the women who used either the DigniCap or another scalp cooling system, the Paxman, lost less than 50 percent of their hair.
"These findings appear to represent a major step forward in improving the quality of life of individuals with cancer," says Dr. Dawn Hershman, who studies the effects of cancer treatments at the Columbia University School of Medicine in New York. She wrote an editorial accompanying the studies in JAMA, the journal of the American Medical Association.
But Hershman cautions that more study is needed to determine whether there is psychological benefit in using the caps to prevent hair loss.
And the cost and who will pay for the treatment are also issues, she says. The average cost is $1,500 to $3,000, depending on the number of chemotherapy cycles.
In the DigniCap study, 67 of 106 women (66.3 percent) lost less than half their hair after four rounds of taxane chemotherapy. The women had either stage I or II breast cancer.
In contrast, all of the 16 women who did not use the cap lost all of their hair during chemotherapy.
The DigniCap system uses a double cap fitted to the scalp 30 minutes before an infusion, which keeps the scalp at 37 degrees Fahrenheit, plus or minus 2 degrees, during the session. The system was approved by the FDA in 2015 and is available at infusion centers in 17 states.
The other study found similar results using the Paxman system. It was led by oncologist Julie Nangia of the Baylor College of Medicine in Houston.
Half of the 95 women (50.5 percent) using the Paxman system lost less than half their hair after four rounds of anthracycline and taxane chemotherapy, including five women who had no significant hair loss, as judged by independent observers from photographs.
Among the 47 who did not use the cooling system, all lost all of their hair.
The Paxman study was stopped earlier than planned, after four cycles of chemotherapy, because findings showed the cooling cap was highly effective at preventing hair loss. That cooling system is not yet available commercially in the U.S. and is under review at the FDA.
"It's nice now to have two good studies focusing on the quality of life to make the cancer journey easier for women," Nangia tells NPR.
There were no serious side effects related to either cooler. A few people reported headaches, and some stopped using the device because they got too cold. Nangia says most patients described the device as "reasonably comfortable."
The studies were funded and designed, in part, by their respective manufacturers, with varying levels of company input to the university investigators. In both cases, the researchers were free to publish results they deemed appropriate.
Researchers don't know exactly how the cooling caps work. One theory is that cooling constricts the blood vessels in the scalp, slowing the circulation and thereby reducing the amount of toxins to which hair follicles are exposed.
Or it may be that cold slows the growth of hair follicles, making them less susceptible to damage from chemotherapy, which targets rapidly dividing cells.
Dr. Len Lichtenfeld, deputy chief medical officer of the American Cancer Society, says it could be that "by slowing down those cells whatever mechanism it may be — either starving their blood flow or slowing them down straightforwardly — the net effect is beneficial, causing hair not to fall out."
While chilling the scalp may seem to carry few risks, Lichtenfeld says there is a theoretical risk that inhibiting the effect of chemotherapy in the scalp could allow metastases to take hold there.
"These techniques are relatively new," he says, and "breast cancer is a disease that can take a long time before it comes back and if one is to be 100 percent certain then you need a long period of time to answer the question."
So far, cancer recurrence on the scalp has not been seen in the U.S. studies, but authors of both JAMA papers say longer follow-up is needed to be sure that this is not a risk.
KELLY MCEVERS, HOST:
Many women with breast cancer consider hair loss one of the most traumatic things about chemotherapy. Some turn to cooling caps to help prevent baldness, but they haven't been studied extensively in the U.S., and they don't always work. Now researchers say a new kind of cooling cap system used before and during chemo could help prevent baldness. NPR's Patti Neighmond reports.
PATTI NEIGHMOND, BYLINE: When Shawna Mayberry was 58 years old and diagnosed with breast cancer, she expected to lose her hair during chemotherapy, but she didn't. She was part of a study looking at the effectiveness of a cooling cap system that covers the scalp and delivers liquid coolant before, during and after chemo.
SHAWNA MAYBERRY: You know what it felt like? I used to live in Indiana, and in the summer, we had an outdoor pool. And I was on the swim team. And I loved diving in that water when it was kind of cold because it gives you a rush. This was the same thing.
NEIGHMOND: Even comforting, she says. Now, not everyone in this study felt this way. Some experience discomfort or headaches. Others dropped out of a study because the cold was too much to bear. But for patients like Mayberry who used the cap during every session of chemo hair loss was reduced by at least half.
MAYBERRY: That helped me feel normal. When I looked in the mirror, I saw me. I didn't see someone that was ill. And that was wonderful.
NEIGHMOND: Now, Mayberry's hair thinned a bit, she says, but not much. She didn't need a scarf or a wig. And when people found out she was on chemo, they couldn't believe it. Oncologist Julie Nangia headed the study.
JULIE NANGIA: We found that half of the women who used the scalp-cooling device kept their hair - at least half of their hair and not needing to use a wig.
NEIGHMOND: Women in the control group did not use the cooling device.
NANGIA: Nobody kept their hair, so there was a hundred percent hair loss.
NEIGHMOND: A second study also in this week's Journal of the American Medical Association had similar results. Women who wore the cap reduced their hair loss by at least 50 percent. Nangia says the findings are one more step toward better treatments and therapies for breast cancer patients.
NANGIA: And I think it's nice now to have two good studies that really are focusing on quality of life to make that cancer journey easier for women.
NEIGHMOND: Researchers don't know exactly how the cap works. It could be the cold temperatures constrict blood vessels and prevent chemo drugs from getting to hair follicles, or it could be the cold slows metabolism of hair cells and reduces the uptake of the drugs. Oncologist Leonard Lichtenfeld with the American Cancer Society...
LEONARD LICHTENFELD: By slowing down those cells, whatever the mechanism may be - by starving their blood flow or slowing them down straightforwardly - has the net benefit of causing the hair not to fall out.
LICHTENFELD: Cooling treatment is evolving, he says, and researchers should make sure inhibiting the effect of chemotherapy doesn't cause metastasis in the scalp later on.
LICHTENFELD: Breast cancer is a disease that can take a long time until it comes back. One wants to be absolutely 100 percent certain, then you need that long period of time to answer the question.
NEIGHMOND: Both studies plan to answer that question over the long term and follow up with patients for at least five years. Treatment with the cooling cap system isn't cheap. It can cost up to $3,000 and is usually not covered by insurance. Patti Neighmond, NPR News.
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