A Randomized Trial Evaluating Resistance Training and Dietary Supplements as Intervention for Regaining Muscle Mass Following Radiotherapy in Head and Neck Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Muscle mass and muscle strength
研究概览
简要总结
The purpose of this study is to investigate whether resistance training in combination with dietary supplementation is tolerable among head and neck cancer patients and to evaluate the possible effect on muscle mass, strength and functional capacity.
详细描述
Head and neck cancer patients experience a significant loss of muscle mass following radiotherapy treatment due to cachexia and dysphagia. This negatively affects muscle strength and functional capacity.
Studies on healthy individuals and various groups of patients show that resistance training in combination with protein and creatine ingestion is an effective means of increasing muscle mass, strength and functional capacity.
Thus the aim is to investigate the following:
- is resistance training and dietary supplements tolerable among head and neck cancer patients
- the effect of the intervention on muscle mass, strength and functional capacity
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
- Double (Participant, Outcomes Assessor)
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
- •head and neck cancer patients (localized to the larynx, pharynx and oral cavity) treated with curative radiotherapy
- •complete loss of tumor
- •WHO performance status between 0-1 and expected ability to complete the training protocol
- •No parenteral feeding
- •above the age of 18
- •written concent
排除标准
- •other malignant diseases
- •pregnancy
- •undergoing systematic resistance training or creatin ingestion
- •Alcohol abuse
研究组 & 干预措施
resistance training and dietary supplement
干预措施: Resistance training (Other)
resistance training and dietary supplement
干预措施: Protein and creatine (Dietary Supplement)
Resistance training and placebo ingestion
12 weeks of resistance training and placebo ingestion
干预措施: Resistance training (Other)
Resistance training and placebo ingestion
12 weeks of resistance training and placebo ingestion
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Muscle mass and muscle strength
时间窗: 13 weeks
次要结局
- Functional capacity(13 weeks)
研究者
Jens Overgaard
Professor, MD
Danish Head and Neck Cancer Group