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.

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%).