1. Less hair loss was observed in women who received scalp cooling prior to the start of adjuvant chemotherapy for early-stage breast cancer.
2. Improved quality of life measures were observed with the use of this scalp cooling device.
Evidence Rating Level: 2 (Good)
Study Rundown: Hair loss remains one of the most distressing adverse effects of chemotherapy. Scalp cooling has been utilized extensively in Europe to reduce chemotherapy-related alopecia. Newer technologies including the use of a scalp cooling device with a running coolant have provided advantages over frozen caps that require regular coordinated changes. In this multicenter prospective cohort study, the association between scalp cooling and alopecia was investigated in women undergoing adjuvant chemotherapy (excluding combination chemotherapy with anthracyclines) for early-stage breast cancer. Among women who received scalp cooling, 66.3% lost less than half of their hair by 4 weeks after their final cycle of chemotherapy, as compared to 0% in the control group. Those that received scalp cooling also showed significantly improved quality of life measures including feeling more physically attractive.
Overall, this study suggests that the use of a scalp cooling device helps reduce hair loss and improves quality of life in women undergoing adjuvant chemotherapy for early-stage breast cancer. Relative strengths of the study include its multicenter nature and use of specific chemotherapy regimen to help with standardization. The study is limited in its application due to the small sample size and the exclusion of alopecia-inducing anthracycline regimens. Further, while the non-blinded patient assessment of the primary end point of hair loss may also pose a possible limitation, success rates obtained from this method were overall supported from a blinded independent panel utilized during the study. Future directions may include evaluating the role of anthracycline regimens and longer-term adverse effects.
In-Depth [prospective cohort]: Under an investigational device exemption from the FDA, a scalp cooling device (DigniCap, Digitana AB) was studied at 6 sites between August 2013 and October 2014. An age- and chemotherapy-matched control group was included in the study. Scalp cooling was initiated 30 minutes prior to each chemotherapy cycle and maintained at 3oC throughout the infusion and for 90 to 120 minutes afterward. Prevention of hair loss 4 weeks after completion of all chemotherapy cycles comprised the primary end point, while patient-reported adverse effects comprised the secondary end points. Photographs of patients’ hair were taken before and 3 to 6 weeks after the start of each chemotherapy cycle. Both the patients’ (non-blinded) and independent raters (blinded) measured the degree of hair loss in the photographs using the Dean scale. Quality of life was measured at baseline, at the start of the last chemotherapy cycle, and 1 month later using the European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire.
A total of 117 patients were enrolled in the study (n = 101 in scalp cooling group; n = 16 in control group). Mean age was 53 years, 77.0% were white, 9.0% were black, and 10.7% were Asian. Docetaxel and cyclophosphamide comprised the most common chemotherapy regimen, and the mean duration of chemotherapy was 2.3 months. Of 101 patients in the scalp cooling group, 67 (66.3%; 95%CI, 56.2%-75.4%) showed 50% or less hair loss (Dean score 0-2) compared with 0 of 16 (0%) in the control group (p < 0.001). Similarly, the independent panel demonstrated 74 (of 88 patients examined) with less than 50% of hair loss. Quality of life responses were significantly different in 3 of 5 measured variables, including fewer women feeling less physically attractive (27.3% of patients vs. 56.3% in the control group). At the time of study, no patient had developed scalp metastases. Follow-up will continue for up to 5 years.
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