Efficacy of EPA-enriched Supplement Compared With Standard Formula on Body Weight Changing in Malnourished Head and Neck Cancer Patients Undergone Surgery: A Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change from baseline in Body weight at 3 weeks
研究概览
简要总结
The purpose of this study is to study the effects of EPA-enriched supplement compared with conventional supplement in malnourished head and neck cancer patients undergone surgery. Primary outcome is perioperative weight changing.
详细描述
To study the effects of EPA-enriched supplement compared with conventional supplement in malnourished head and neck cancer patients undergone surgery. The patients are divided into 2 groups receiving the different formula supplements. The both supplements are isocaloric. The patients receive the supplement for 3 weeks (1 week prior to surgery and 2 weeks post surgery) Primary outcome is perioperative weight changing. Secondary outcomes are body compositions, hospital stay days, complication and co-morbidity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed as Head an Neck cancer with pathological confirmation
- •Receiving surgery as a primary treatment
- •Malnutrition screening tool(MST) is 2 or more
排除标准
- •Previously irradiated patient in the Head and Neck region
- •Previously receiving chemotherapy
- •Renal insufficiency with serum creatinine > 2.5 mg/dL
- •Liver function abnormality with total serum bilirubin > 3.0 mg/dL
结局指标
主要结局
Change from baseline in Body weight at 3 weeks
时间窗: 3 weeks
Body weight measured in kilogram
Change from baseline in Body weight at 1 month
时间窗: 1 month
Body weight measured in kilogram
Change from baseline in Body weight at 3 months
时间窗: 3 months
Body weight measured in kilogram
次要结局
- Change from baseline in fat-free mass percentage at 3 weeks(3 weeks)
- Change from baseline in fat-free mass percentage at 1 month(1 month)
- Change from baseline in fat-free mass percentage at 3 months(3 months)
- Change from baseline in body fat percentage at 3 weeks(3 weeks)
- Change from baseline in body fat percentage at 1 month(1 month)
- Change from baseline in body fat percentage at 3 months(3 months)
研究者
Kitti Jantharapattana, M.D.
Assistant Professor
Prince of Songkla University