Pilot Study: Randomized Controlled Trial on the Influence of an Oral Nutritional Supplement Rich in Omega-3 Fatty Acids on Functional State and Quality of Life in Malnourished Patients With Gastroenterological Tumors
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- improvement of muscle function (hand grip strength, respiratory muscle function) at two months
研究概览
简要总结
Malnutrition is a frequent symptom of various malignant diseases and is frequently observed in patients with gastrointestinal tumors. Eicosapentanoic acid (EPA) has been introduced as specific and anticatabolic acting substrate in cancer patients. Only few randomized trials are available which investigated the effect of EPA in form of an EPA-enriched, protein- and energy-dense oral nutritional supplement mostly in patients with pancreatic carcinoma.
Therefore, the effect of an EPA-rich oral nutritional supplement for two months on functional state and quality of life in patients with other gastroenterological tumors and weight loss is investigated in this randomized prospective trial.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •malignant disease: colorectal neoplasm, hepatocellular carcinoma, cholangiocarcinoma
- •palliative treatment of malignant disease: UICC stage >1
- •impaired nutritional state: weight loss > 5% body weight in the preceding 6 months or subjective global assessment grade B (moderately malnourished) or grade C (severely malnourished)
- •informed written consent
排除标准
- •age < 18 years
- •pregnancy
- •exclusive enteral or parenteral nutrition
- •taking of eicosapentanoic acid in form of fish oil capsules
- •contraindications for oral nutrition (i.e. ileus, uncontrollable vomiting)
- •terminal stage of disease with a life expectancy < 3 months
- •missing or withdrawn consent
- •simultaneous participation in another trial
结局指标
主要结局
improvement of muscle function (hand grip strength, respiratory muscle function) at two months
improvement of cognitive function at two months
improvement of quality of life at two months
次要结局
- tolerance of the oral nutritional supplement
- improvement of nutritional state (body weight, muscle mass, body cell mass, phase angle, serum albumin)