Abstract：
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.
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.
摘要：
目的：头颈部肿瘤患者在放疗过程中经常发生放射性皮炎（RD）。我们比较了含和不含洋甘菊提取物的脂质体凝胶在头颈部癌症放疗患者中预防和管理RD的作用。
方法：在一项双盲随机临床试验中招募了60名首次接受头颈部肿瘤放疗的参与者。主要结果是干脱屑的发生和第一次发生干脱屑时电离辐射的累积剂量。次要结果是红斑的发生，潮湿的脱屑，全局RD,和参与者自我报告的症状。
结果：在洋甘菊脂质体凝胶组中76.9％（95％CI：57.9，89.0）的参与者和88.9％（95％CI：71.9，96.1）的参与者中发生了干脱屑。脂质体凝胶组（p=0.43）。发生干脱屑时，洋甘菊脂质体凝胶组为48.0Gy，脂质体凝胶组为40.0Gy。在洋甘菊脂质体凝胶组中报告的症状较少。
结论：两组间结局无统计学差异，尽管洋甘菊脂质体凝胶组的RD等级低于脂质体凝胶组。此外,与其他主题干预措施管理RD的文献相比，我们的结果表明，洋甘菊脂质体凝胶有可能更好地管理和预防该人群的RD，这应该进一步测试。这项研究为设计未来的研究提供了重要信息。临床试验注册（REBEC）：RBR-92cts3。
方法：在一项双盲随机临床试验中招募了60名首次接受头颈部肿瘤放疗的参与者。主要结果是干脱屑的发生和第一次发生干脱屑时电离辐射的累积剂量。次要结果是红斑的发生，潮湿的脱屑，全局RD,和参与者自我报告的症状。
结果：在洋甘菊脂质体凝胶组中76.9％（95％CI：57.9，89.0）的参与者和88.9％（95％CI：71.9，96.1）的参与者中发生了干脱屑。脂质体凝胶组（p=0.43）。发生干脱屑时，洋甘菊脂质体凝胶组为48.0Gy，脂质体凝胶组为40.0Gy。在洋甘菊脂质体凝胶组中报告的症状较少。
结论：两组间结局无统计学差异，尽管洋甘菊脂质体凝胶组的RD等级低于脂质体凝胶组。此外,与其他主题干预措施管理RD的文献相比，我们的结果表明，洋甘菊脂质体凝胶有可能更好地管理和预防该人群的RD，这应该进一步测试。这项研究为设计未来的研究提供了重要信息。临床试验注册（REBEC）：RBR-92cts3。
