Scalp cooling reduces hair loss in breast cancer chemo patients

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Among women with stage I to II breast cancer receiving chemotherapy, 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, found two randomised clnical trials.

Chemotherapy may result in hair loss (alopecia), which women rate as one of the most distressing adverse effects of chemotherapy. Scalp cooling is hypothesised to reduce blood flow to hair follicles and reduce uptake of chemotherapeutic agents. Modern methods to prevent hair loss use devices that circulate fluid in a cooling cap using refrigeration. A cap is placed on the patient prior to chemotherapy and does not have to be changed or removed until the treatment is completed.

Although scalp cooling devices have been used to prevent alopecia, efficacy has not been assessed in a randomised clinical trial.

In one study, Dr Julie Nangia, of the Baylor College of Medicine, Houston, and colleagues randomly assigned 182 women with breast cancer undergoing chemotherapy to scalp cooling (n = 119) or control (n = 63). Scalp cooling was done 30 minutes prior to and during and 90 minutes after each chemotherapy infusion. Hair preservation was assessed at the end of four cycles of chemotherapy. One interim analysis was planned to allow the study to stop early for efficacy.

At the time of the interim analysis, 142 participants were evaluable. The researchers found that patients who received scalp cooling were significantly more likely than patients who did not receive scalp cooling to have less than 50% hair loss (with 51% of those in the scalp cooling group retaining their hair, compared with 0% of those in the control group). There were no significant differences in changes in any of the measures of quality of life between the groups. Only adverse events related to device use were collected; 54 adverse events were reported in the cooling group, none serious.
“Further research is needed to assess longer-term efficacy and adverse effects,” the authors write.

In another study, Dr Hope S Rugo, of the University of California – San Francisco, and colleagues included women with breast cancer receiving chemotherapy (106 patients in the scalp cooling group and 16 in the control group; 14 matched by both age and chemotherapy regimen). Scalp cooling was initiated 30 minutes prior to each chemotherapy cycle, with scalp temperature maintained at 3°C (37°F) throughout chemotherapy and for 90 minutes to 120 minutes afterward.

Although scalp cooling has been available for several decades in Europe, use has been limited in the US because of several factors, including insufficient prospective efficacy data with current chemotherapy regimens and lack of US Food and Drug Administration (FDA) clearance.

Among the 122 patients in the study, the average duration of chemotherapy was 2.3 months. Hair loss of 50% or less was seen in 67 of 101 patients (66%) evaluable for alopecia in the scalp cooling group vs 0 of 16 patients (0%) in the control group. Three of five quality-of-life measures were significantly better one month after the end of chemotherapy in the scalp cooling group. Of patients who underwent scalp cooling, 27% reported feeling less physically attractive compared with 56% of patients in the control group. Of the 106 patients in the scalp cooling group, four (3.8%) experienced the adverse event of mild headache and three (2.8%) discontinued scalp cooling due to feeling cold.

“Further research is needed to assess outcomes after patients receive anthracycline [a class of drugs used in chemotherapy] regimens, longer-term measures of alopecia, and adverse effects,” the authors write.

Abstract 1
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.

Authors
Julie Nangia, Tao Wang, Cynthia Osborne, Polly Niravath, Kristen Otte, Steven Papish, Frankie Holmes, Jame Abraham, Mario Lacouture, Jay Courtright, Richard Paxman, Mari Rude, Susan Hilsenbeck, C. Kent Osborne, Mothaffar Rimawi

Abstract 2
Importance: Chemotherapy-induced alopecia is a common and distressing adverse effect. In previous studies of scalp cooling to prevent chemotherapy-induced alopecia, conclusions have been limited.
Objectives: To evaluate whether use of a scalp cooling system is associated with a lower amount of hair loss among women receiving specific chemotherapy regimens for early-stage breast cancer and to assess related changes in quality of life.
Design, Setting, and Participants: A prospective cohort study conducted at 5 US medical centers of women with stage I or II breast cancer receiving adjuvant or neoadjuvant chemotherapy regimens excluding sequential or combination anthracycline and taxane (106 patients in the scalp cooling group and 16 in the control group; 14 matched by both age and chemotherapy regimen). The study was conducted between August 2013 and October 2014 with ongoing annual follow-up for 5 years.
Exposures: Use of a scalp cooling system. Scalp cooling was initiated 30 minutes prior to each chemotherapy cycle, with scalp temperature maintained at 3°C (37°F) throughout chemotherapy and for 90 minutes to 120 minutes afterward.
Main Outcomes and Measures: Self-estimated hair loss using the Dean scale was assessed 4 weeks after the last dose of chemotherapy by unblinded patient review of 5 photographs. A Dean scale score of 0 to 2 (≤50% hair loss) was defined as treatment success. A positive association between scalp cooling and reduced risk of hair loss would be demonstrated if 50% or more of patients in the scalp cooling group achieved treatment success, with the lower bound of the 95% CI greater than 40% of the success proportion. Quality of life was assessed at baseline, at the start of the last chemotherapy cycle, and 1 month later. Median follow-up was 29.5 months.
Results: Among the 122 patients in the study, the mean age was 53 years (range, 28-77 years); 77.0% were white, 9.0% were black, and 10.7% were Asian; and the mean duration of chemotherapy was 2.3 months (median, 2.1 months). No participants in the scalp cooling group received anthracyclines. Hair loss of 50% or less (Dean score of 0-2) was seen in 67 of 101 patients (66.3%; 95% CI, 56.2%-75.4%) evaluable for alopecia in the scalp cooling group vs 0 of 16 patients (0%) in the control group (P < .001). Three of 5 quality-of-life measures were significantly better 1 month after the end of chemotherapy in the scalp cooling group. Of patients who underwent scalp cooling, 27.3% (95% CI, 18.0%-36.6%) reported feeling less physically attractive compared with 56.3% (95% CI, 31.9%-80.6%) of patients in the control group (P = .02). Of the 106 patients in the scalp cooling group, 4 (3.8%) experienced the adverse event of mild headache and 3 (2.8%) discontinued scalp cooling due to feeling cold.
Conclusions and Relevance: Among women undergoing non–anthracycline-based adjuvant chemotherapy for early-stage breast cancer, the use of scalp cooling vs no scalp cooling was associated with less hair loss at 4 weeks after the last dose of chemotherapy. Further research is needed to assess outcomes after patients receive anthracycline regimens, longer-term measures of alopecia, and adverse effects.

Authors
Hope S Rugo, Paula Klein, Susan Anitra Melin, Sara A Hurvitz, Michelle E Melisko, Anne Moore, Glen Park, Jules Mitchel, Erika Bågeman, Ralph B D’Agostino, Elizabeth S Ver Hoeve, Laura Esserman, Tessa Cigler

JAMA material
JAMA abstract 1
JAMA abstract 2


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