title: Association Between Use of a Scalp Cooling Device and Alopecia After Chemotherapy for Breast Cancer.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  clinicaltrials.gov Identifier: NCT01831024.
authors.affiliation: Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco.
authors.forename: Hope S
authors.initials: HS
authors.lastname: Rugo
authors.affiliation: Icahn School of Medicine at Mount Sinai, New York, New York.
authors.forename: Paula
authors.initials: P
authors.lastname: Klein
authors.affiliation: Wake Forest Baptist Health Medical Center, Wake Forest School of Medicine, Winston-Salem, North Carolina.
authors.forename: Susan Anitra
authors.initials: SA
authors.lastname: Melin
authors.affiliation: Jonsson Comprehensive Cancer Center, University of California, Los Angeles.
authors.forename: Sara A
authors.initials: SA
authors.lastname: Hurvitz
authors.affiliation: Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco.
authors.forename: Michelle E
authors.initials: ME
authors.lastname: Melisko
authors.affiliation: Weill Cornell Medical College, New York, New York.
authors.forename: Anne
authors.initials: A
authors.lastname: Moore
authors.affiliation: Target Health Inc, New York, New York.
authors.forename: Glen
authors.initials: G
authors.lastname: Park
authors.affiliation: Target Health Inc, New York, New York.
authors.forename: Jules
authors.initials: J
authors.lastname: Mitchel
authors.affiliation: Dignitana AB, Lund, Sweden.
authors.forename: Erika
authors.initials: E
authors.lastname: Bågeman
authors.affiliation: Wake Forest School of Medicine, Winston-Salem, North Carolina.
authors.forename: Ralph B
authors.initials: RB
authors.lastname: D'Agostino
authors.affiliation: Columbia University, New York, New York10Now with the Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
authors.forename: Elizabeth S
authors.initials: ES
authors.lastname: Ver Hoeve
authors.affiliation: Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco.
authors.forename: Laura
authors.initials: L
authors.lastname: Esserman
authors.affiliation: Weill Cornell Medical College, New York, New York.
authors.forename: Tessa
authors.initials: T
authors.lastname: Cigler
mesh_terms: D000328:Adult; D000368:Aged; D000505:Alopecia / Q000139:chemically induced / Q000175:diagnosis / Q000517:prevention & control* / Q000523:psychology; D018943:Anthracyclines / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D001952:Bridged-Ring Compounds / Q000008:administration & dosage / Q000009:adverse effects; D017024:Chemotherapy, Adjuvant; D005260:Female; D006261:Headache / Q000209:etiology; D006801:Humans; D007036:Hypothermia, Induced / Q000009:adverse effects / Q000379:methods*; D008488:Medical Illustration; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D010781:Photography; D011446:Prospective Studies; D011788:Quality of Life; D012535:Scalp; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D018943:Anthracyclines; D001952:Bridged-Ring Compounds; D043823:Taxoids; C080625:taxane