University of Brasília, Interdisciplinary Laboratory of Research Applied to Clinical Practice in Oncology, Faculty of Health Sciences, Brasília, Brazil.
University of Brasília, Interdisciplinary Laboratory of Research Applied to Clinical Practice in Oncology, Faculty of Health Sciences, Brasília, Brazil; University of Brasília, Laboratory of Oral Histopathology, Faculty of Health Sciences, Brasília, Brazil.
Radiother Oncol. 2024 Oct;199:110440. doi: 10.1016/j.radonc.2024.110440. Epub 2024 Jul 19.
Head and neck cancer patients frequently develop radiation dermatitis (RD) during radiotherapy. We compared liposomal gel with and without chamomile extract for the prevention and management of RD in head and neck cancer patients undergoing radiotherapy.
Sixty participants undergoing radiotherapy for the first time for head and neck cancer were recruited in a double-blind randomized clinical trial. Primary outcomes were the occurrence of dry desquamation and the cumulative dose of ionizing radiation at the first occurrence of dry desquamation. Secondary outcomes were the occurrence of erythema, moist desquamation, global RD, and participant self-reported symptoms.
Dry desquamation occurred in 76.9 % (95 % CI: 57.9, 89.0) of participants in the chamomile liposomal gel group and in 88.9 % (95 % CI: 71.9, 96.1) in the liposomal gel group (p = 0.43). The median cumulative dose of ionizing radiation when dry desquamation occurred was 48.0 Gy in the chamomile liposomal gel group and 40.0 Gy in the liposomal gel group. Fewer symptoms were reported in the chamomile liposomal gel group.
No statistically significant differences in outcomes were found between the two groups, though the chamomile liposomal gel group presented with lower grades of RD than the liposomal gel group. In addition, when compared to the literature on other topical interventions to manage RD, our results show that chamomile liposomal gel has potential for better management and prevention of RD in this population, which should be further tested. This study provides crucial information to design future studies. Clinical Trials Registration (REBEC): RBR-92cts3.
头颈部癌症患者在放疗过程中常发生放射性皮炎（RD）。我们比较了含有和不含有洋甘菊提取物的脂质体凝胶在预防和管理头颈部癌症放疗患者 RD 方面的效果。
在一项双盲随机临床试验中，招募了 60 名首次接受头颈部癌症放疗的患者。主要结局是干性脱皮的发生和首次发生干性脱皮时电离辐射的累积剂量。次要结局是红斑、湿性脱皮、整体 RD 和患者自我报告的症状的发生。
洋甘菊脂质体凝胶组中 76.9%（95%可信区间：57.9，89.0）的患者发生干性脱皮，脂质体凝胶组中 88.9%（95%可信区间：71.9，96.1）的患者发生干性脱皮（p=0.43）。发生干性脱皮时电离辐射的累积剂量中位数在洋甘菊脂质体凝胶组为 48.0 Gy，在脂质体凝胶组为 40.0 Gy。洋甘菊脂质体凝胶组报告的症状较少。
两组间的结局无统计学差异，但洋甘菊脂质体凝胶组的 RD 分级低于脂质体凝胶组。此外，与其他用于管理 RD 的局部干预措施的文献相比，我们的结果表明，洋甘菊脂质体凝胶在该人群中具有更好的 RD 管理和预防潜力，这需要进一步的测试。本研究为未来的研究提供了关键信息。临床研究注册（REBEC）：RBR-92cts3。
