Progressive Resistance Training as Intervention for Regaining Muscle Mass After Radiation Therapy in Patients With HNSCC - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Body composition
研究概览
简要总结
Head and neck cancer patients often experience a critical weight loss of around 10% following radiation therapy. Of this up to 70% is muscle mass and is an independent predictor of mortality, lowers muscle strength and functional performance. The purpose of this study is in a randomized controlled trial to investigate the effects of progressive resistance training (PRET) on changes in muscle mass, muscle strength and functional performance in head and neck cancer survivors. The investigators hypothesize that PRET has a positive effect on all primary endpoints and increases muscle mass, muscle strength and functional performance.
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 (Investigator, 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
- •Histologically diagnosed with squamous cell carcinomas of the larynx (no glottis stage I+II), pharynx, oral cavity or in lymph nodes from an unknown primary tumour (stage I-IV and tumour node metastasis (TNM) classification, UICC, Geneva, 1987)
- •Terminated curative radiotherapy treatment with/without chemotherapy;
- •No metastases
- •Complete tumour remission
- •No current or previous malignancies that could prevent participation and training
- •No excessive alcohol intake (men > 21 and women > 14 units/wk)
- •No recent systematic resistance training or creatine ingestion (within 2 months)
- •If woman, not pregnant
- •WHO performance status of 0-1
- •No psychological, social or geographical conditions that could disturb participation
- •Written consent
排除标准
- 未提供
结局指标
主要结局
Body composition
时间窗: Baseline, 3 months and 6 months
Lean body mass and fat mass assessed by DEXA scanning
次要结局
- Chair rise capacity(Baseline, 3 months, 6 months)
- Maximal muscle strength(Baseline, 3 months and 6 months)
- Maximal gait speed(Baseline, 3 months and 6 months)
- Patient reported outcomes(Baseline, 3 months and 6 months)
- Blood sampling(Baseline, 3 months and 6 months)
- 30 s arm curl capacity(Baseline, 3 months, 6 months)
- Stair climbing capacity(Baseline, 3 months, 6 months)
- Jumping capacity(Baseline, 3 months, 6 months)
研究者
Jens Overgaard
Professor, MD
Danish Head and Neck Cancer Group