Meneses Amanda Gomes de, Ferreira Elaine Barros, Vieira Larissa Aparecida Corrêa, Bontempo Priscila de Souza Maggi, Guerra Eliete Neves Silva, Ciol Marcia Aparecida, Reis Paula Elaine Diniz Dos
Interdisciplinary Laboratory of Research Applied to Clinical Practice in Oncology, Faculty of Health Sciences, University of Brasilia, DF 70910-900, Brasília, Brazil.
Laboratory of Oral Histopathology, Faculty of Health Sciences, University of Brasilia, Brasília, Brazil.
Strahlenther Onkol. 2025 Feb;201(2):115-125. doi: 10.1007/s00066-024-02293-9. Epub 2024 Sep 12.
To compare a liposomal gel with and without chamomile extract for the prevention of radiation dermatitis in breast cancer patients undergoing radiotherapy.
This study was a double-blind randomized clinical trial. A total of 100 participants undergoing radiotherapy for breast cancer were recruited. The primary outcome was the occurrence of dry desquamation. Cumulative dose of ionizing radiation at the first occurrence of dry desquamation, occurrence of erythema, moist desquamation, global radiation dermatitis, and any signs and symptoms self-reported by participants were secondary outcomes.
Dry desquamation occurred in 6.0% of the participants using chamomile liposomal gel and 12.2% of those using liposomal gel (p = 0.32). The mean cumulative dose of ionizing radiation for the first occurrence of dry desquamation was 45.1 Gy in the chamomile liposomal gel group and 43.7 Gy in the liposomal gel group. There were no differences between the two gels in the occurrence of erythema, dry desquamation, moist desquamation, and radiation dermatitis compared to liposomal gel. There was a lower proportion of reported symptoms in the chamomile liposomal gel group compared to liposomal gel group in the first 3 weeks of radiation, especially for itching (p = 0.05).
No statistically significant differences between the two gels were found in radiation dermatitis occurrence and dose at first occurrence. Comparing to the literature, it seems that both interventions may be effective, which might explain the lack of statistical difference between the groups.
比较含和不含洋甘菊提取物的脂质体凝胶对接受放疗的乳腺癌患者放射性皮炎的预防作用。
本研究为双盲随机临床试验。共招募了100名接受乳腺癌放疗的参与者。主要结局是干性脱皮的发生情况。首次出现干性脱皮时的电离辐射累积剂量、红斑、湿性脱皮、总体放射性皮炎的发生情况以及参与者自我报告的任何体征和症状为次要结局。
使用洋甘菊脂质体凝胶的参与者中6.0%出现干性脱皮，使用脂质体凝胶的参与者中12.2%出现干性脱皮（p = 0.32）。洋甘菊脂质体凝胶组首次出现干性脱皮时的平均电离辐射累积剂量为45.1 Gy，脂质体凝胶组为43.7 Gy。与脂质体凝胶相比，两种凝胶在红斑、干性脱皮、湿性脱皮和放射性皮炎的发生情况上没有差异。在放疗的前3周，洋甘菊脂质体凝胶组报告的症状比例低于脂质体凝胶组，尤其是瘙痒（p = 0.05）。
在放射性皮炎的发生情况及首次发生时的剂量方面，两种凝胶之间未发现统计学上的显著差异。与文献相比，似乎两种干预措施都可能有效，这可能解释了两组之间缺乏统计学差异的原因。
