Effect of a Scalp Cooling Device on Alopecia in Women Undergoing Chemotherapy for Breast Cancer

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 PARTICIPANTSMulticenter 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 MEASURESThe 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.

Scalp cooling with adjuvant/neoadjuvant chemotherapy for breast cancer and the risk of scalp metastases: systematic review and meta-analysis

“…Fourteen studies were excluded for the following reasons: No follow-up or unclear follow-up time following completion of chemotherapy (total of 10) [21–30]; patients used scalp cooling for treatment of metastatic disease (total of 2) [31, 32]; treatment for breast cancer was not specified (one study) [33]; and one study was excluded due to unclear cancer type at presentation [34] (Table 2). …”

“…No length of follow-up noted. No scalp metastases notedNangia et al [30]No long-term follow-up on patients in randomized controlled trialPeck et al [27]One patient in scalp cooling group subsequently presented with scalp metastasis. However, patient already had widespread metastatic cancer ( n  = 10); unclear as to follow-upSatterwhite [28]One patient in scalp cooling group already had scalp metastasis ( n  = 12); no follow-upvan den Hurk [29]Breast cancer patients treated with chemotherapy in the Dutch scalp cooling registry ( n  = 1216).…”

“…Based on these factors, we believe the weighted mean value is a reasonable approximation of the follow-up timeframes. Follow-up on scalp cooling patients over a longer period of time is ongoing [17, 30]. …”

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

“…Scalp cooling has been studied in a randomized clinical trial that included patients with breast cancer receiving combination anthracycline and taxane regimens. 33 Third, the choice of a patient-assessed end point rather than by independent raters masked to treatment group is another limitation; however, this end point was carefully considered. Compared with a blinded panel, patient scores were generally lower in a 20-patient pilot study using the same scalp cooling system 34 as used in the current study.…”

Pathogenesis and treatment options for chemotherapy‐induced alopecia: a systematic review

“…The SCALP randomized trial analyzed the efficacy of the “Paxman” cooling device in preventing CIA in women undergoing chemotherapy for breast cancer. SC was graded as successful (defined as <50% hair loss not requiring a wig) in 50.5% of cooled patients compared to 0% of the control group ( p = 0.0061) . SC should be considered a potential preventive option for CIA in patients with solid tumors who are receiving high‐risk CIA regimens.…”