Skeletal Muscle Atrophy and Dysfunction in Human Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Mitochondrial function
研究概览
简要总结
Cancer and its treatment can have profound effects on skeletal muscle, the most well-recognized being atrophy, weakness and diminished oxidative capacity. These adaptations negatively impact quality of life, treatment decisions and survival. Despite these consequences, the factors promoting these adaptations remain poorly defined and understudied in human patients. To address this gap in knowledge, our goal in this study is to examine the role of muscle disuse as a regulator of muscle size and function in human cancer patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50-75 yrs of age
- •histologically-documented, stage III or IV non-small cell lung carcinoma (NSCLC)
- •estimated life expectancy >6 mos
- •Karnofsky's performance score of ≥70
排除标准
- •history, signs or symptoms of inflammatory or autoimmune disease
- •uncontrolled hypertension
- •heart or renal failure
- •exercise limitations from peripheral vascular disease or stroke
- •neuromuscular disease
- •knee/hip replacement
- •additional, actively-treated malignancy or history of malignancy, except non-melanoma skin cancer
- •taking medication that can have anti-coagulant effects that cannot be stopped prior to the muscle biopsy
结局指标
主要结局
Mitochondrial function
时间窗: Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
Mitochondrial function will be assessed on isolated mitochondria
Cross-sectional area of skeletal muscle fibers
时间窗: Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
Cross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types
Mitochondrial content
时间窗: Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
Mitochondrial content will be assessed by electron microscopy.
Single muscle fiber contractile function
时间窗: Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
Segments of chemically-skinned single human muscle fibers will be assessed for cellular and molecular contractile parameters under maximal calcium-activated conditions, with muscle fiber type determined post-measurement by gel electrophoresis
次要结局
- Whole muscle isokinetic function(Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks)
- Whole muscle isometric function(Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks)
- Whole muscle size(Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks)
研究者
Michael J. Toth, Ph.D.
Associate Professor of Medicine
University of Vermont