Standard Hypercaloric, Hyperproteic vs Leucine-enriched Oral Supplements in Patients With Cancer-induced Sarcopenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Muscle mass gain
研究概览
简要总结
Currently there is a lack of evidence for recommending specific oral supplements (OS) for nutritional support in patients with cancer, including leucine-enriched supplements.
详细描述
Appropriate clinical trials that compare anthropometric and biochemical changes in nutritional parameters and clinical outcomes in patients with cancer-induced sarcopenia are required
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients of both sexes, age > 18 y-old
- •cancer of different origin treated with systemic treatment chemo, radiotherapy or combination treatment t
- •weight loss >5% during the previous three months or >10% during the previous six months
排除标准
- •end-stage kidney disease
- •life expectancy < 2 weeks
研究组 & 干预措施
Standard hypercaloric, hyperproteic oral supplement
Patients will receive 2 supplements per day (Standard hypercaloric, hyperproteic oral supplement)
干预措施: Standard hypercaloric hyperproteic oral nutritional supplement (Dietary Supplement)
Leucin-enriched hypercaloric, hyperproteic oral supplement
Patients will receive 2 supplements per day (Leucin-enriched hypercaloric, hyperproteic oral supplement)
干预措施: Leucine-enriched hypercaloric hyperproteic oral nutritional supplement (Dietary Supplement)
结局指标
主要结局
Muscle mass gain
时间窗: 3 Months
Changes in Muscle mass (%) determined by BIA and echography
次要结局
- Changes in albumin(3 Months)
- Changes in prealbumin(3 Months)
- Fat mass change(3 Months)
- Phase angle change(3 Months)
- Changes in CRP(3 Months)
研究者
Aura Herrera
Principal Investigator
Maimónides Biomedical Research Institute of Córdoba