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.

• Authors: Katharina Smetanay, Philippe Junio, Manuel Feißt, Julia Seitz, Jessica Cecile Hassel, Luisa Mayer, Lina Maria Matthies, Arina Schumann, André Hennigs, Jörg Heil, Christof Sohn, Dirk Jaeger, Andreas Schneeweiss, Frederik Marmé
• Journal: Breast cancer research and treatment (Breast Cancer Res Treat) Vol. 173 Issue 1 Pg. 135-143 (Jan 2019) ISSN: 1573-7217 [Electronic] Netherlands
• PMID: 30255454 (Publication Type: Journal Article, Randomized Controlled Trial)

Topics

• Adult
• Aged
• Aged, 80 and over
• Alopecia (chemically induced, prevention & control)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Breast Neoplasms (drug therapy)
• Female
• Hair
• Humans
• Hypothermia, Induced (methods)
• Middle Aged
• Neoadjuvant Therapy (adverse effects, methods)
• Prospective Studies
• Quality of Life
• Scalp