the Safety and Effectiveness of Protein Supplements on Cancer Patients With Nutritional Risk and Malnutrition
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- blood toxicity
研究概览
简要总结
Nutritional risk and malnutrition is common in cancer patients, which is one of the significant factors affecting the overall survival, toxicity during anticancer treatment, and quality of life among patients with cancer. Previous studies have shown that the increased protein intake can stimulate muscle synthesis, and improve muscle mass, strength, function, overall survival, and quality of life. The current study is going to investigate the effectiveness and safety of protein supplements on patients with cancer, in order to provide a reference for further nutrition treatment.
详细描述
An anticipated total of 100 participants will randomly assigned to receive either a 20-gram protein supplement per day or nutrition counseling to increase the protein intake. there will be a total of 3 study visits, and dietary assessment and blood sample collection will occur at every study visit. Intention-to-treat analysis (ITT) and per-protocol analysis (PP) will be used in statistical analysis.
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
- Single (Outcomes Assessor)
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
- •• Age>=18years old;
- •Initial treatment patients with lung/gastrointestinal/esophageal cancer
- •Patients with nutritional risk (NRS-2002≥3) ;
- •Patients are able to provide written informed consent.
排除标准
- •• People who are allergic to whey protein.
- •Participants received any drugs or supplements known to influence the outcomes, such as protein powder, anabolic steroids, or glucocorticoids before the 3 months preceding the study.
- •Participants with gastrointestinal bleeding or intestinal obstruction, or any contraindication for oral intake
- •Concurrent severe cardiac disease, liver and renal failure, which may significantly interfere with study compliance.
- •Participants with electronic or mental device.
- •Women in pregnancy or lactation period
研究组 & 干预措施
protein supplements
This group will receive dietary guidance and protein supplements for 3 months
干预措施: protein supplement (Dietary Supplement)
protein supplements
This group will receive dietary guidance and protein supplements for 3 months
干预措施: nutrition counseling (Behavioral)
dietary guidance
this group will receive dietary guidance for 3 months
干预措施: nutrition counseling (Behavioral)
结局指标
主要结局
blood toxicity
时间窗: 6 month
blood toxicity based on Common Terminology Criteria for Adverse Events (CTCAE)
nutritional risk
时间窗: 6 months
nutritional risk based on nutrition risk screening-2002 (NRS-2002)
malnutrition
时间窗: 6 months
malnutrition assessment based on Global Leadership Initiative on Malnutrition (GLIM)
次要结局
- phase angle (PA)(6 month)
- dose limitation(6 months)
- weight(6 month)