NCT01645150已完成不适用
Pilot Study on the Effects of Strength Training on Cancer Related Fatigue in Cancer Patients During Tyrosine Kinase Inhibitor Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in cancer related fatigue
研究概览
简要总结
The purpose of this pilot study is to determine the effects of a 12-week resistance training program on cancer related fatigue in cancer patients receiving tyrosine kinase inhibitor (TKI) therapy. It is hypothesized that incidence and severity of cancer related fatigue can be reduced by exercise training in this population which leads to an improved treatment completion rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female cancer patients
- •Prior to tyrosine kinase inhibitor therapy (any substance, any line)
- •Age: at least 18 yrs
- •Body mass index (BMI): at least 18 kg/m2
- •ECOG performance status: at most 2
- •Must be able to meet the requirements of the study protocol
排除标准
- •Acute infectious diseases
- •No ambulatory ability
- •Severe neurological disorders
- •Severe cardiovascular diseases
- •Severe pulmonary insufficiency
- •Severe renal insufficiency
- •Other current tumor diseases
- •Conditions rendering compliance impossible
- •Participation in regular strength training
结局指标
主要结局
Change in cancer related fatigue
时间窗: From baseline to the 6th and 12th week of training.
Assessed via the Multidimensional Fatigue Inventory (MFI).
次要结局
- Change in body composition(From baseline to the 12th week of training)
- Change in muscle strength of the knee extensor, hip flexor and forearm flexor muscles.(From baseline to the 12th week of training.)
- Change in quality of life(From baseline to the 6th and 12th week of training.)
- Change in endurance capacity(From baseline to the 12th week of training.)
- Change in depression(From baseline to the 6th and 12th week of training.)
- Time of the first tumor progression under TKI therapy(Within the first 6 months of TKI therapy)
- Time of reduction or replacement of TKI therapy(Within the first 6 months of TKI therapy)
研究者
研究点 (2)
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