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COOLHAIR: a prospective randomized trial to investigate the efficacy and tolerability of scalp cooling in patients undergoing (neo)adjuvant chemotherapy for early breast cancer

Abstract

Purpose

Chemotherapy-induced alopecia (CIA) is a distressing side effect for women with breast cancer undergoing chemotherapy. Scalp cooling is a method aiming to prevent CIA, but its efficacy is not well defined. Randomized trials until recently and at the time this trial was designed have been lacking.

Methods

Patients undergoing (neo)adjuvant chemotherapy for early breast cancer (EBC) were randomized to scalp cooling (CAP) or observation (NoCAP). All patients received 18–24 weeks of anthracycline- and/or taxane-based chemotherapy. The primary endpoint was patient-reported rate of alopecia according to a modified version of the Dean Scale. Hair preservation was defined as hair loss ≤ grade 2 (≤ 50%). Secondary endpoints were rate of alopecia determined by medical staff, rate of wig/scarf use, tolerability as well as quality of life (QoL).

Results

Seventy-nine patients were randomized. Hair preservation was observed in 39.3% of patients in the CAP arm versus 0% in the NoCAP arm (p < 0.001). Wig/scarf use was significantly less frequent in the CAP group (40.7% vs 95.5% outside home before cycle 3, p < 0.001). The drop-out rate was 31.7% and 34.2% in the CAP and NoCAP arm, respectively. Main reasons for drop-out were hair loss, adverse events (CAP), and randomization into control arm. We observed no differences in efficacy between anthracycline-based and non-anthracycline-based regimens. QoL did not differ between the study arms.

Conclusions

This trial adds to the evidence that scalp cooling effectively prevents CIA in a meaningful number of patients. This option should be made available for patients undergoing (neo)adjuvant chemotherapy for EBC.

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Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

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Correspondence to Katharina Smetanay.

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Conflict of interest

Jessica C. Hassel has had a paid consulting role with Merck and Amgen, and has received honoraria from Bristol-Myers Squibb, Merck, Novartis, Roche, and Pfizer. Dirk Jaeger received honoraria from Bayer, Amgen, MSD, CureVac, Roche, BMS, and Definiens. Andreas Schneeweiss received honoraria from Roche, Celgene, Pfizer, AstraZeneca, and Novartis. Frederik Marmé has received honoraria and travel expenses from Roche, Amgen, AstraZeneca, Eisai, and Celgene. Novartis, Pfizer, PharmaMar, Genomic Health, and CureVac. All remaining authors have declared no conflicts of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institution and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Additional information

Awards:

Katharina Smetanay received a Merit Award at the American Society of Clinical Oncology (ASCO) Annual Meeting for the submitted abstract.

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Cite this article

Smetanay, K., Junio, P., Feißt, M. et al. COOLHAIR: a prospective randomized trial to investigate the efficacy and tolerability of scalp cooling in patients undergoing (neo)adjuvant chemotherapy for early breast cancer. Breast Cancer Res Treat 173, 135–143 (2019). https://doi.org/10.1007/s10549-018-4983-8

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Keywords

  • Alopecia
  • Breast cancer
  • Chemotherapy
  • Scalp cooling
  • Quality of life