Evaluating acceptance of scalp cooling in patients receiving chemotherapy for primary gynecologic cancers: Lessons from a randomized controlled trial.

11127 Background: Scalp cooling is effective in preventing chemotherapy-induced alopecia (CIA) in cancer patients. However, its effect and acceptance are not certain in gynecologic cancer patients particularly in Asia. Methods: The CHARM study was a single-center randomized study. Women with proven gynecologic cancer planning for 3-weekly carboplatin and paclitaxel were randomised to receive usual care (control group) or scalp cooling using the Paxman Orbis II system (Paxman Coolers Limited, Huddersfield, United Kingdom) (intervention group). The primary endpoint was the incidence of psychological distress, i.e., Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) score ≥10. The study was approved by the Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster (UWB 19-514). Results: Between November 2019 to November 2021,142 women were invited to join the study. 56 women (39.4%) declined to participate, and the most common reason was worries about coldness (Table 1). 44 women were randomized to the intervention group and 42 to the control group. Fewer women in the intervention had psychological distress compared to the control group after cycle 2 of chemotherapy (27.8% vs 62.2%, p=0.003). The incidence of Grade ≥ 3 adverse events were similar between both groups (7.5% vs 5.1%, p=1.0). However, 12 out of 40 (30.0%) in the intervention group did not comply with scalp cooling, among which nine (75%) were due to feeling cold despite measures like using blankets and hot water. Conclusions: Scalp cooling was associated lesspsychological distress in Asian women using chemotherapy for gynecologic cancer. Nevertheless, the high refusal rate to join the study and high drop-out rate limited its use in these women. This might be partially due to some misbelief that associated head coldness with poor general health in Traditional Chinese Medicine. More strategies are needed to improve the acceptance of scalp cooling. Clinical trial information: NCT04168242 . Reasons for refusal to join the study. Reasons Number of women (%) Worries of coldness 34 (60.7%) Worries of musculoskeletal pain/headache 2 (3.6%) Psychiatric stress 2 (3.6%) Personal image 4 (7.1%) Logistic issue 3 (5.4%) Unknown reasons 11 (19.6%) Total 56