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首页> 外文期刊>Canadian Journal of Mathematics >Safety and Tolerability of Targeted Medical Nutrition for Cachexia in Non-Small-Cell Lung Cancer: A Randomized, Double-Blind, Controlled Pilot Trial
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Safety and Tolerability of Targeted Medical Nutrition for Cachexia in Non-Small-Cell Lung Cancer: A Randomized, Double-Blind, Controlled Pilot Trial

机译：非小细胞肺癌患者患者靶向医学营养的安全性和耐受性：随机，双盲，受控试验试验

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Background: This pilot, double-blind, comparator-controlled trial evaluated the safety and tolerability of an oral targeted medical nutrition (TMN) supplement for the management of cachexia in patients with non-small-cell lung cancer (NSCLC). Methods: Patients receiving first-line chemotherapy for NSCLC with weight loss or low BMI were randomized 1:1 to receive juice-based TMN (similar to 200 kcal; 10 g whey protein; >= 2.0 g eicosapentaenoic acid/docosahexaenoic acid in fish oil; and 10 mu g 25-hydroxy-vitamin D3) or a milk-based isocaloric comparator twice daily for 12 weeks (ClinicalTrials.gov: NCT02515032). Primary endpoints included number/type of adverse events and changes in vital signs/laboratory parameters. Secondary endpoints included measures of clinical relevance. Survival was an exploratory endpoint. Results: The TMN group (n = 26; mean 64.4 years) experienced fewer adverse events (64 vs. 87) than the comparator group (n = 29; mean 66.0 years), including fewer cases of neutropenia (0 vs. 4). Compliance was slightly lower in the TMN (58.5%) vs. comparator group (73.6%). There were no statistically significant between-group differences in efficacy endpoints. Fewer (4 vs. 10) patients who received TMN than comparator had died by 1-year post baseline. Conclusions: TMN was well tolerated. Trends for improved clinical outcomes with TMN identified in this study warrant further investigation.
机译：背景：该试点，双盲，比较试验评估了非小细胞肺癌（NSCLC）患者管理恶病症管理的口服有针对性的医学营养（TMN）的安全性和耐受性。方法：对具有减肥或低BMI的NSCLC接受一线化疗的患者随机化1：1接受基于果汁的TMN（类似于200千卡; 10g乳清蛋白;> = 2.0g eicosapentaeno酸/鱼油中的十二碳六烯酸;和10μg25-羟基 - 维生素D3）或牛奶基同种大理素比较剂每日两次，12周（ClinicalTrials.gov：NCT02515032）。主要终点包括不良事件的数量/类型，以及生命体征/实验室参数的变化。辅助端点包括临床相关性的测量。生存是一个探索性终点。结果：TMN组（n = 26;平均64.4岁）经历了比对比剂组（n = 29;平均66.0岁）的不良事件（64 vs.87），包括较少的中性粒细胞病例（0 vs.4）。在TMN（58.5％）对比较器组（73.6％）中的顺应性略低。疗效终点的组间差异没有统计学意义。收到TMN的患者比比较者的患者更少，而1年后的基线已经死亡。结论：TMN耐受良好。在本研究中确定的TMN改善临床结果的趋势需要进一步调查。

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