The Effect of Nutritional Supplementation in Cancer Patients With no Clinical Signs of Malnutrition
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Improvement of nutritional status
研究概览
简要总结
The aim of the study was to assess the effect of nutritional supplementation on nutritional status and postoperational complications in cancer patients with no clinical signs of malnutrition
详细描述
In previous psychological studies our team found high level psychological stress in over 60% of cancer patients. This may cause numerous problems including anorexia, which together with biological disturbances can initiate cancer related catabolism even when it can not yet be seen. In this study we want to answer the question if oral nutritional supplementation can help the patient overcome the catabolism in its initial phase and improve nutritional status, which would result in reduced number of postoperational complications
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Primary or secondary resectable gastrointestinal and abdominal malignancy
- •No signs of malnutrition at qualification for surgery
- •General performance >70 Karnofsky scale
- •Informed consent
排除标准
- •history of radio or chemotherapy
- •signs of mechanical ileus
- •other major gastrointestinal diseases
- •type 1 diabetes
- •autoimmunological diseases requiring systemic steroids
- •signs of infection
- •renal and/or liver failure
研究组 & 干预措施
Nutritional supplements
Patients are asked to drink two 200ml bottles of nutritional supplement daily
干预措施: Nutritional supplements (Dietary Supplement)
Control
Patients are asked to keep on to their normal diet. No supplementation is introduced
结局指标
主要结局
Improvement of nutritional status
时间窗: After 14 days
The aim of the study was to assess if nutritional supplementation improves nutritional status of patients with no clinical signs of malnutrition. Nutritional status improvement will be assessed by change in anthropometric (body weight (kg)) and laboratory (albumin, total protein, transferrin level, total lymphocyte count) parameters.
次要结局
- Reducing number of complications(30 days after surgery)