Key Points 
 
 Question What is the effectiveness of a scalp cooling device in preventing alopecia in women with breast cancer undergoing neoadjuvant or adjuvant chemotherapy? 
 
 Findings In a randomized clinical trial of 182 women with breast cancer receiving chemotherapy with a taxane, anthracycline, or both, those who underwent scalp cooling were significantly more likely to have less than 50% hair loss compared with no scalp cooling (50.5% vs 0%). The trial was stopped early for superiority, and there was no effect on measures of quality of life. 
 
 Meaning This scalp cooling system was more likely to prevent alopecia than no treatment, and further research is needed to assess longer-term efficacy and adverse effects. 
 
 Abstract 
 
 Importance Chemotherapy may induce alopecia. Although scalp cooling devices have been used to prevent this alopecia, efficacy has not been assessed in a randomized clinical trial. 
 
 Objectives To assess whether a scalp cooling device is effective at reducing chemotherapy-induced alopecia and to assess adverse treatment effects. 
 
 Design, Setting, and Participants Multicenter randomized clinical trial of women with breast cancer undergoing chemotherapy. Patients were enrolled from December 9, 2013, to September 30, 2016. One interim analysis was planned to allow the study to stop early for efficacy. Data reported are from the interim analysis. This study was conducted at 7 sites in the United States, and 182 women with breast cancer requiring chemotherapy were enrolled and randomized. 
 
 Interventions Participants were randomized to scalp cooling (n = 119) or control (n = 63). Scalp cooling was done using a scalp cooling device. 
 
 Main Outcomes and Measures The primary efficacy end points were successful hair preservation assessed using the Common Terminology Criteria for Adverse Events version 4.0 scale (grade 0 [no hair loss] or grade 1 [<50% hair loss not requiring a wig] were considered to have hair preservation) at the end of 4 cycles of chemotherapy by a clinician unaware of treatment assignment, and device safety. Secondary end points included wig use and scores on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Core 30, Hospital Anxiety and Depression Scale, and a summary scale of the Body Image Scale. 
 
 Results At the time of the interim analysis, 142 participants were evaluable. The mean (SD) age of the patients was 52.6 (10.1) years; 36% (n = 51) received anthracycline-based chemotherapy and 64% (n = 91) received taxane-based chemotherapy. Successful hair preservation was found in 48 of 95 women with cooling (50.5%; 95% CI, 40.7%-60.4%) compared with 0 of 47 women in the control group (0%; 95% CI, 0%-7.6%) (success rate difference, 50.5%; 95% CI, 40.5%-60.6%). Because the 1-tailed P value from the Fisher exact test was <.001, which crossed the superiority boundary (P = .0061), the data and safety monitoring board recommended study termination on September 26, 2016. There were no statistically significant differences in changes in any of the scales of quality of life from baseline to chemotherapy cycle 4 among the scalp cooling and control groups. Only adverse events related to device use were collected; 54 adverse events were reported in the cooling group, all grades 1 and 2. There were no serious adverse device events. 
 
 Conclusions and Relevance Among women with stage I to II breast cancer receiving chemotherapy with a taxane, anthracycline, or both, those who underwent scalp cooling were significantly more likely to have less than 50% hair loss after the fourth chemotherapy cycle compared with those who received no scalp cooling. Further research is needed to assess longer-term efficacy and adverse effects. 
 
 Trial Registration clinicaltrials.gov Identifier: NCT01986140 ||||| Cooling Cap May Limit Chemo Hair Loss In Women With Breast Cancer 
 
 Enlarge this image toggle caption Courtesy of Baylor College of Medicine Courtesy of Baylor College of Medicine 
 
 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. 
 
 Enlarge this image toggle caption Courtesy of Baylor College of Medicine Courtesy of Baylor College of Medicine 
 
 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. ||||| TUESDAY, Feb. 14, 2017 -- Scalp cooling caps can help breast cancer patients save their hair from the ravages of chemotherapy, a pair of new studies suggests. 
 
 More than half of women fitted with cooling caps kept their hair during chemotherapy in the world's first randomized clinical trial of the devices, said lead researcher Dr. Julie Nangia. She is an assistant professor and breast cancer expert with the Baylor College of Medicine in Houston. 
 
 "The trial was stopped early because the device was so effective in the group that got the device," Nangia said. "In our study, half of women who used the scalp cooling device kept their hair, and in the control group there was zero percent hair retention. Everyone who didn't have the device lost their hair." 
 
 A second study also found that the cooling caps could reduce hair loss, with two-thirds of patients losing half or less of their hair during chemotherapy, researchers reported. 
 
 The studies were published Tuesday in the Journal of the American Medical Association. Both received funding from the makers of the cooling devices used in each study, Paxman Coolers of England and Dignitana of Sweden, respectively. 
 
 Scalp cooling caps could help save lives by making chemotherapy more acceptable to breast cancer patients, Nangia said. 
 
 About 50 percent of patients consider hair loss the most traumatic aspect of chemotherapy, and about 8 percent report they would decline chemo because of this concern, an accompanying journal editorial stated. 
 
 "Universally, every woman cries when I tell them they're going to lose their hair. There's a very emotional aspect to it," Nangia said. 
 
 "When you lose your hair, that's part of your body image and your sexuality," she continued. "You also lose your anonymity and privacy. Everybody knows you are sick. You can't just go out and be a normal person." 
 
 The harsh drugs used in chemotherapy cause hair follicles to become weak and break. They also damage hair growth cells in follicles, which can stop the hair growth cycle altogether or cause new hair to shed easily. 
 
 Scalp cooling caps appear to limit this damage by constricting blood vessels in the scalp, reducing the amount of chemo that is delivered to the hair follicles, Nangia explained. The cooling caps also might decrease the biochemical damage done to follicles by whatever chemo does get through. 
 
 Patients put on a tight scalp cooling cap for a half-hour before chemotherapy, and leave it on for 90 minutes to 120 minutes afterward, according to the two studies. 
 
 "The key is to have a tight fit, because if you have any gaps you'll lose hair where there's not good contact," Nangia said. 
 
 Nangia's clinical trial included 182 breast cancer patients. Two-thirds were randomly chosen to receive scalp cooling, and the rest received chemotherapy without a cooling cap. 
 
 However, the trial was halted after data came in for the first 142 patients and it became clear that cooling had a significant effect in slowing or stopping hair loss, Nangia said. 
 
 The second study, conducted at five U.S. medical centers and led by Dr. Hope Rugo from the University of California, San Francisco, involved 101 breast cancer patients fitted with a cooling cap and 16 patients in a control group. Again, all patients without the cap lost their hair, while hair loss was limited or halted in those who used the scalp cooling cap. 
 
 The risk of hair loss varied widely in both studies, depending on which medical center provided the scalp cooling therapy and which chemo drugs were used in treatment, said Dr. Len Lichtenfeld, deputy chief medical officer for the American Cancer Society. He was not involved with the research. 
 
 The amount of experience a center had with the devices appeared to improve their ability to preserve hair, and the relative harshness of the patient's chemotherapy also seemed to play a role, Lichtenfeld explained. 
 
 "These devices do prevent hair loss in some women, but it's very much operator-dependent and chemotherapy-dependent," Lichtenfeld said. 
 
 Scalp cooling devices cost between $1,500 and $3,000 per patient in the United States, and aren't reimbursed by health insurance, Nangia's study noted. That's not counting the time and cost of applying the device during chemo, Lichtenfeld added. 
 
 Neither study found any short-term adverse effects caused by the cooling caps. But, there are worries that cancer might reappear in a woman's scalp years after treatment, said Lichtenfeld and Dr. Richard Bleicher, breast clinical service line leader with Fox Chase Cancer Center in Philadelphia. 
 
 Bleicher, who's also an associate professor of surgical oncology at Fox Chase, said that "there has been some concern that if less chemotherapy circulates to the scalp, breast cancer metastases could have a greater likelihood of occurring there." 
 
 Nangia acknowledged concerns that restricting flow of chemo to the scalp could protect cancer cells hiding there. 
 
 Both research teams plan to follow patients for at least five years to see if there's any increased risk for cancer recurrence. Nangia added that previous European studies have found no effect on long-term cancer survival. 
 
 For more about scalp cooling, visit the American Cancer Society. 
 
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– Cooling caps are massively popular with European chemo patients and have been making inroads into the US, but two studies published Tuesday in the Journal of the American Medical Association offer some of the first clinical proof of their effectiveness. In one study, approximately two-thirds of breast cancer patients lost less than half their hair; in the other study, approximately half of breast cancer patients lost less than half their hair. The New York Times reports 5% of patients kept all their hair. The differences in effectiveness between the studies could have to do with the cooling caps being used, the medical centers applying the caps, and the chemo drugs involved, according to HealthDay News. The studies were funded by two different companies that manufacture cooling caps. Cooling caps are affixed to patients' heads before, during, and after chemo; a machine cycles cooling liquid through the caps. While researchers aren't exactly sure how the caps prevent hair loss, NPR reports, one theory is they restrict blood vessels in the scalp, reducing the amount of chemo that reaches the hair follicles. About half of breast cancer patients say hair loss is the most daunting part of chemo, and 8% say they would turn down chemo in order to keep their hair. One breast cancer survivor who used a cooling cap says it has psychological benefits. She tells the Times that losing their hair makes people "think they're sicker than they actually are." (A dose of magic mushrooms had a big effect on cancer patients.)