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

Conflict of interest statement

Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. No other disclosures were reported.

Figures

Figure 1. Flowchart of Patients in Scalp Cooling Trial

The primary analysis estimate of hair loss included all eligible patients who received at least 1 cycle of chemotherapy and who did not discontinue scalp cooling due to adverse effects of chemotherapy or a major protocol violation (nonadherence). Patients electing not to undergo scalp cooling were enrolled in the concurrent control group. Patients in the control group were matched retrospectively to a patient at the same investigative site by age (within 5 years) and the same chemotherapy regimen.

Figure 2. Photographic Results of 2 Patients Treated With Scalp Cooling

A, Patient photographs from 4 different angles before the start of chemotherapy cycle 1 (Dean score of 0; hair loss of 0%) and 1 month after completion of 4 cycles of chemotherapy with docetaxel (60 mg/m2) and cyclophosphamide (600 mg/m2) (Dean score of 1; hair loss >0%-≤25%). B, Patient photographs from 4 different angles before the start of chemotherapy cycle 1 (Dean score of 0) and 1 month after completion of 4 cycles of chemotherapy with docetaxel (60 mg/m2) and cyclophosphamide (600 mg/m2) (Dean score of 4; hair loss >75%).