A Clinical Trial With Nutritional Intervention to Evaluate the Effect of an Specific Oral Nutritional Supplement on the Nutritional Status in Patients With Cancer and Malnutrition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Nutritional status
研究概览
简要总结
Effect of a specific nutritional oral supplement on the nutritional status of patients with cancer and malnutrition
详细描述
Multicentric, parallel, randomized, double blind and controlled clinical-nutritional study of 8 weeks of duration and 2 study groups of treatment: Experimental group (experimental nutritional oral supplement); and Control group (control nutritional oral supplement) to evaluate the effect on the nutritional and functional status, the quality of life and body composition of patients with cancer and malnutrition undergoint specficic treatment (chemotherapy, radiotherapy, inmunotherapy).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 28 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women over 18 with a cancer diagnosis (any type).
- •Subjects who have initiated during the next mont a treatment with chemo and or radiotherapy with or without surgery.
- •Having lost more than 5% of body weight in the last 6 months.
- •Adequate cultural level and understanding for the clinical trial.
- •Signed informed consent.
排除标准
- •Subjects who are participating in other clinical trials.
- •Subjects with morbid obesity.
- •Subjects who will undergo surgery or who will undergo.
- •Subjects with cachexia
- •Subjects with infection of a cause other than of the tumor
- •Subjects with an infectious process
- •Subjects with Diabetes Mellitus treated with insulin and/or not controlled
- •Subjects with kidney, heart, respiratory or liver disease.
- •Subjects with autoimmune diseases.
- •Subjects with mental illness or decrease function cognitive.
- •Subjects who consume oral supplements or artificial nutrition and who cannot be withdran at least 1 week before startint the study.
- •Patients who have consumed food supplements or fortified foods in omega 3 (arginine or nucleotides) during the previous month.
- •Patients who reject oral supplements.
- •Pregnant or breastfeeding women.
- •Allergic to any component of the formula
研究组 & 干预措施
Experimental Group
Nutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement
干预措施: Experimental Group (Dietary Supplement)
Control group
Nutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement
干预措施: Control Group (Dietary Supplement)
结局指标
主要结局
Nutritional status
时间窗: Change from baseline to day 142
Subjective Global Assessment (SGA)
次要结局
- Eastern Cooperative Oncology Group Scale (ECOG)(Change from baseline to day 142)
- Body composition(Change from baseline to day 142)
- Diet quality(Change from baseline to day 142)
- Functional status(Change from baseline to day 142)