The efficacy of scalp cooling in patients receiving chemotherapy for primary gynecologic cancers: a randomized controlled trial.

Scalp cooling can prevent chemotherapy-induced alopecia in breast cancer patients. But data in gynecologic patients were scarce. The CHARM study was a single-center randomized study. Women planning for 3-weekly carboplatin and paclitaxel were randomized to either scalp cooling or usual clinical practice in 1:1 ratio. The primary endpoint was the efficacy in hair preservation after the completion of chemotherapy as assessed by the clinicians. Secondary endpoints included quality of life, the incidence of psychological distress, and safety. 142 women were invited to join the study but 56 refused. Finally, 44 women were randomized to the intervention group and 42 to the control group. The successful rate in preserving hair, defined as Dean score ≤ 2, upon completion of chemotherapy was significantly higher in the intervention group (29.6%, 95% confidence interval (CI) 12.4–46.9%) than the control group (0%, 95% CI 0–0%) (p = 0.002). Compared to the control group, the intervention group had significantly better global health status, physical functioning, and role functioning during the chemotherapy, lower incidence of psychological distress after cycle 2 of chemotherapy (27.8% vs. 62.2%, p = 0.003), and lower median PHQ-ADS scores after cycle 2 (5.5 vs. 11.0, p = 0.045) and 2–3 weeks post-chemotherapy (5.0 vs. 9.0, p = 0.033). However, the intervention group had a 30% drop-out rate despite no major adverse events. Scalp cooling could reduce the incidence of CIA and potentially alleviate psychological distress and improve the QOL in gynecologic cancer patients. Further effort is needed to improve the acceptance and compliance rates in Asian population. (ClinicalTrials.gov number, NCT04168242).