Efficacy of scalp cooling system versus chemical cooling cap in preventing chemotherapy-induced alopecia in breast cancer (COHAIR Study): a prospective randomized trial.

[INTRODUCTION] A prospective, randomized trial was conducted at a tertiary cancer hospital, to investigate the efficacy of scalp cooling system and chemical cooling cap in preventing chemotherapy-induced alopecia (CIA) in early breast cancer.

[METHODS] Patients were randomly assigned to scalp cooling system group or chemical cooling cap group. Alopecia was assessed using the World Health Organization toxicity grading scale for anticancer drug and Quality of life and psychological status were evaluated using the European Organization for Research and Treatment of Cancer Quality of life Questionnaire Core 30 and the Hospital Anxiety and Depression Scale.

[RESULTS] A total of 152 patients were included in the random grouping process. The mean age of the participants was 44.6 ± 9.0 years (range 27-65 years), and 97.4% patients were diagnosed invasive ductal carcinoma. Among 117 patients completed the observation period with four cycles of anthracycline followed by four cycles of taxane regimen, hair preservation success rates were 74.5% in scalp cooling system and 71.2% in chemical cooling cap group and demonstrated good tolerability. The chemical group showed significantly lower anxiety scores and better QoL.

[CONCLUSIONS] Cooling therapies effectively improved CIA. Scalp cooling showed superior early efficacy during anthracycline treatment, while chemical cooling provided better psychological outcomes and QoL benefits. Disease-free survival (DFS) was comparable between groups.

[CLINICAL TRIAL REGISTRATION] NCT03711877 on 26 November 2021.