Influence of a Specially Formulated Whey Protein Supplement in Combination With Physical Exercise and Nutrition Program on Physical Performance in Cancer Outpatients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in physical performance
研究概览
简要总结
This study evaluates physical performance in cancer outpatients during a multimodal therapy. Half of the patients will receive physical exercise und nutrition program in combination with a specially formulated whey protein supplement, while the other half will receive standard care.
详细描述
The time period of Intervention will last 3 month, measurements will be conducted at baseline and 3 month. After 6 month there will be an additional follow-up test point to assess the sustainability of the intervention. The 3-month intervention study consists of a physical exercise program and nutrition counseling in combination with a specially formulated whey protein supplement high in leucine. The standardized training program will be performed twice a week in the physical department of the Kantonsspital Winterthur (KSW) and once a week in a home based setting. Additionally, participants of the intervention group will be aks to consume 15 g of the nutrient supplement powder with approximately 150 ml water. On workout days the supplement should be taken twice a day and on the remaining days once a day. During the three month intervention study participants will take part in a nutrition counseling for at least three times.
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
- •Advanced cancer patients not eligible for curative treatment: lung cancer, gastrointestinal cancer, breast cancer, prostate cancer, ovarian cancer, pleural mesothelioma, urothelium carcinoma, renal cell carcinoma
- •WHO performance status ≥ 2
- •Able to walk independently at least 100 meters
- •Estimated life expectancy of ≥ 6 month
排除标准
- •Patients currently using nutritional supplements with branched chain amino acids
- •Enteral or parenteral nutrition within 1 month
- •History of ileus within 1 month
- •Psychiatric disorder precluding understanding of information on trials related topics and giving informed consent
- •Milk protein allergy
研究组 & 干预措施
Intervention group
Participants will receive physical exercise, nutrition counseling and a whey protein Supplement over 12 weeks
干预措施: nutrition counseling (Behavioral)
Intervention group
Participants will receive physical exercise, nutrition counseling and a whey protein Supplement over 12 weeks
干预措施: physical exercise (Behavioral)
Intervention group
Participants will receive physical exercise, nutrition counseling and a whey protein Supplement over 12 weeks
干预措施: whey protein supplement (Dietary Supplement)
Control group
Participants will receive standard care
结局指标
主要结局
Change in physical performance
时间窗: measured at week 0, 12 and 24
Physical performance will be assessed with the short physical performance battery
次要结局
- Change in physical function(measured at week 0, 12 and 24)
- Change in diet history(measured at week 0, 12 and 24)
- Overall survival(up to 24 weeks)
- Change in nutritional status(measured at week 0, 12 and 24)
- Number of re-hospitalization(up to 24 weeks)
- Change in body composition(measured at week 0, 12 and 24)
- Change in quality of life(measured at week 0, 12 and 24)
- Change in fatigue(measured at week 0, 12 and 24)
- Change in WHO performance status(measured at week 0, 12 and 24)