早期营养干预对头颈部癌放疗患者口腔黏膜炎及基本状况的影响：随机对照试验（ChiCTR2000031418）。
Effects of early nutritional intervention on oral mucositis and basic conditions in patients receiving radiotherapy for head and neck cancer: Randomized controlled trial (ChiCTR2000031418).
机构信息
Department of Radiation Oncology, The First Hospital of Jilin University, Changchun 130021, China; Jilin Provincial Key Laboratory of Radiation Oncology & Therapy, The First Hospital of Jilin University, Changchun, 130021, China; NHC Key Laboratory of Radiobiology, School of Public Health of Jilin University, Changchun, 130021, China.
出版信息
Clin Nutr. 2024 Jul;43(7):1717-1723. doi: 10.1016/j.clnu.2024.05.029. Epub 2024 May 22.
BACKGROUND & AIMS: This study aims to observe the effects of early nutritional intervention on radiation-induced oral mucositis (OM) and the nutritional status of patients with head and neck cancer (HNC) receiving radiotherapy.
METHODS
Eligible patients receiving radiotherapy for HNC were randomly divided into an early nutritional intervention group (enteral nutritional intervention was administered at the beginning of radiotherapy) and a late nutritional intervention group (enteral nutritional intervention was administered at the beginning of eating restriction) in a 1:1 ratio. The primary endpoint was radiation-induced OM. Secondary endpoints included nutrition-related indicators, immune function, overall survival (OS), progression-free survival (PFS), quality of life, and other radiotherapy-induced adverse effects.
RESULTS
A total of 100 patients were enrolled between 2020 and 2021, including 50 each in the early nutritional intervention group and in the late group. The incidence of Grade-III/IV OM was lower in the early treatment group than in the late treatment group (2% vs 14%, P = 0.059). By week 7 weight loss was significantly lower in the early group than in the late group (1.08 kg, 95% CI: 0.08-2.09, P = 0.035). Regarding the PG-SGA scores after receiving radiotherapy, the early group comprised more well-nourished and fewer malnourished patients than those in the late group (P = 0.002). The scores of the immune function indices of T cell CD3, CD4/CD8, and B cell CD19 were slightly higher in the early group than in the late group; however, the difference was not statistically significant (all P > 0.05). PFS and OS were better in the early group than in the late group; however, the differences were not statistically significant (P > 0.05).
CONCLUSIONS
Early nutritional intervention can effectively improve the nutritional status and reduce the incidence of high-grade OM in patients with HNC receiving radiotherapy.
TRIAL REGISTRATION
Chinese Clinical Trials Registry (http://www.chictr.org.cn).
CHICTR-ID: ChiCTR2000031418.
背景与目的
本研究旨在观察早期营养干预对头颈部癌（HNC）患者接受放疗时放射性口腔黏膜炎（OM）和营养状况的影响。
方法
将符合条件的 HNC 放疗患者以 1:1 的比例随机分为早期营养干预组（放疗开始时进行肠内营养干预）和晚期营养干预组（开始限制进食时进行肠内营养干预）。主要终点为放射性 OM。次要终点包括营养相关指标、免疫功能、总生存（OS）、无进展生存（PFS）、生活质量和其他放疗相关不良反应。
结果
2020 年至 2021 年期间共纳入 100 例患者，每组各 50 例。早期治疗组 III/IV 级 OM 的发生率低于晚期治疗组（2%比 14%，P=0.059）。第 7 周时，早期组体重减轻明显低于晚期组（1.08kg，95%CI：0.08-2.09，P=0.035）。放疗后 PG-SGA 评分方面，早期组营养良好的患者多于晚期组，营养不良的患者少于晚期组（P=0.002）。早期组 T 细胞 CD3、CD4/CD8 和 B 细胞 CD19 的免疫功能指标评分略高于晚期组，但差异无统计学意义（均 P>0.05）。早期组 PFS 和 OS 均优于晚期组，但差异无统计学意义（P>0.05）。
结论
早期营养干预可有效改善 HNC 放疗患者的营养状况，降低重度 OM 的发生率。
试验注册
中国临床试验注册中心（http://www.chictr.org.cn）。
注册号
ChiCTR2000031418。
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