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Original Investigation
February 14, 2017

Association Between Use of a Scalp Cooling Device and Alopecia After Chemotherapy for Breast Cancer

Author Affiliations
  • 1Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco
  • 2Icahn School of Medicine at Mount Sinai, New York, New York
  • 3Wake Forest Baptist Health Medical Center, Wake Forest School of Medicine, Winston-Salem, North Carolina
  • 4Jonsson Comprehensive Cancer Center, University of California, Los Angeles
  • 5Weill Cornell Medical College, New York, New York
  • 6Target Health Inc, New York, New York
  • 7Dignitana AB, Lund, Sweden
  • 8Wake Forest School of Medicine, Winston-Salem, North Carolina
  • 9Columbia University, New York, New York
  • 10Now with the Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
JAMA. 2017;317(6):606-614. doi:10.1001/jama.2016.21038
Key Points

Question  Is scalp cooling associated with a lower risk of hair loss when used by women receiving common adjuvant chemotherapy regimens for early-stage breast cancer?

Findings  In this multicenter study, hair loss of 50% or less (Dean score of 0-2) was seen in 66.3% of patients in the scalp cooling group vs 0% of patients in the control group at 4 weeks after completing non–anthracycline-based adjuvant chemotherapy. Three of 5 quality-of-life measurements, including feeling less physically attractive, showed benefit for women who received scalp cooling.

Meaning  This self-contained cooling system was associated with a lower risk of hair loss among women receiving non–anthracycline-based chemotherapy for early-stage breast cancer.

Abstract

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.

Trial Registration  clinicaltrials.gov Identifier: NCT01831024

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