Impact of a Novel Form of Oral Nutritional Supplement Application in Cancer Patients With a High Risk for Malnutrition
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Compliance
研究概览
简要总结
This study evaluates if a novel form of oral nutritional Supplement application in the form of gumdrops may serve as an alternative to common sip Feeds in cancer patients with high risk for malnutrition. Within this context the Impact of these two different supplements on General condition, Quality of life, muscle function, Body composition, Appetite and Nutrition Status are investigated. Patients are randomly allocated either to a study group with oral Supplementation in the form of sip feed or to a study Group receiving gumdrops for 4 weeks. After a washout period of 5-7 days study Groups are switched for another 4 week Intervention period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •adult patients with solid and hematological malignancies
- •BMI < 20 kg/m² and/or NRS-2002 Score ≥ 3
排除标准
- •pregnant or nursing women
- •persons with psychiatric disorders with doubts about legal and cognitive capacity
- •participation in nutritional Intervention Trials within the last 4 weeks
研究组 & 干预措施
Study group 1
normal Nutrition + sip feed (covers individual energy and nutrient demands)
干预措施: sip feed (Dietary Supplement)
Study group 2
normal Nutrition + gumdrops (covers individual energy and nutrient demands)
干预措施: gumdrops (Dietary Supplement)
结局指标
主要结局
Compliance
时间窗: 4 weeks
compliance of nutritional supplement intake assessed by Medication Adherence Report Scale (MARS-D); Total score ranges from 0-10 with a higher score indicating better adherence
Tolerance of the form of oral supplementation
时间窗: 4 weeks
assessment of hedonic and sensoric estimation of oral supplements by questionnaire
次要结局
- Body weight(4 weeks)
- Body composition(4 weeks)
- Physical function - Isometric muscle strength(4 weeks)
- Physical function - Lower limb strength(4 weeks)
- Physical function - Endurance(4 weeks)
- Patient-reported performance status(4 weeks)
- subjective Physical activity(4 weeks)
- objective Physical activity(4 weeks)
- Patient-reported Quality of Life (QoL)(4 weeks)