Feasibility and Effect of Resistance Training and Protein Supplementation in Patients With Advanced Gastroesophageal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Exercise feasibility: Exercise sessions attendance
研究概览
简要总结
Patients with advanced gastroesophageal cancer are in great risk of losing skeletal muscle mass and developing cancer cachexia. Low skeletal muscle mass has a negative impact on quality of life, impairs physical function, increases toxicity from anti-neoplastic treatment, as well as increases risk of death.
Resistance training and protein supplements have the potential to stimulate muscle anabolism and counteract loss of skeletal muscle mass. Therefore, the investigators have designed a randomized controlled feasibility trial to evaluate the feasibility, safety and the therapeutic effect of resistance training and protein supplements in patients with advanced gastroesophageal cancer undergoing first line chemotherapy.
A total of 54 patients with advanced gastroesophageal cancer will be recruited from the Department of Oncology, Copenhagen University Hospital, Rigshospitalet and randomly allocated 2:1 to standard care plus resistance training 3 times pr. week and a daily supplement of protein or to standard care alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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 verified, non-resectable cancer of the esophagus, stomach, or gastroesophageal junction
- •referred to first line chemotherapy.
排除标准
- •Age < 18
- •Living outside the greater Copenhagen area
- •Any other malignancy requiring active treatment
- •Not eligible for chemotherapy
- •Performance status > 2
- •Not able to swallow liquids
- •Parenteral nutrition or enteral nutrition via feeding tube
- •Physical or mental disabilities that prohibit execution of test or training procedures
- •Pregnancy
- •Inability to understand the Danish language
结局指标
主要结局
Exercise feasibility: Exercise sessions attendance
时间窗: From baseline until end of intervention (10 weeks)
The number of attended exercise training sessions relative to the number of planed exercise sessions
Exercise feasibility: Relative dose-intensity of protein supplement
时间窗: From baseline until end of intervention (10 weeks)
The actual amount consumed relative to the amount prescribed over the intervention period
Incidence of Serious Adverse Events (SAEs).
时间窗: Baseline until end of intervention (10 weeks)
SAE will be recorded during trial assessment visits and through medical records. This procedure will concern any SAE during the trial period. For each trial visit we will collect patients' self-report of SAEs, which may have occurred during the period since the last trial visit.
次要结局
- Functional performance: Habituel gait speed(Baseline, end of week 10)
- Muscle strength: Chest press maximal muscle strenght(Baseline, end of week 10)
- Body composition and anthropometrics: Skeletal muscle index(At diagnose, after 10 weeks intervention and at 1 year follow up)
- Body composition and anthropometrics: Skeletal muscle attenuation(At diagnose, end of week 10)
- Exercise feasibility: Relative dose intensity of exercise(Baseline until end of intervention (10 weeks))
- Exercise feasibility: Early termination of exercise sessions(Baseline until end of intervention (10 weeks))
- Body composition and anthropometrics: Muscle thickness(Baseline, end of week 10)
- Resting metabolic rate(Baseline, end of week 10)
- 1 and 2-years cancer-specific survival(Randomization to 1 and 2 years after randomization)
- Health-related quality of life: Social well-being(Baseline, 10 weeks-, 1 year-, and 2 years after randomization)
- Body composition and anthropometrics: Total fat mass(Baseline, end of week 10)
- Body composition and anthropometrics: Bone mineral density(Baseline, end of week 10)
- Body composition and anthropometrics: Adipose tissue index(At diagnose, end of week 10)
- Exercise feasibility: Permanent discontinuation(Baseline until end of intervention (10 weeks))
- Body composition and anthropometrics: Total lean mass(Baseline, end of week 10)
- Body composition and anthropometrics: Appendicular lean mass(Baseline, end of week 10)
- Body composition and anthropometrics: Fat percentage(Baseline, end of week 10)
- Body composition and anthropometrics: Body mass(Baseline, end of week 10)
- Body composition and anthropometrics: Hip circumference(Baseline, end of week 10)
- Body composition and anthropometrics: Waist circumference(Baseline, end of week 10)
- Muscle strength: Leg press maximal muscle strenght(Baseline, end of week 10)
- Heart rate(Baseline, end of week 10)
- Health-related quality of life: gastroesophageal cancer specific(Baseline, 10 weeks-, 1 year-, and 2 years after randomization)
- Self-reported physical activity: Sitting time(Baseline, end of week 10)
- Exercise feasibility: Exercise intervention interruptions(Baseline until end of intervention (10 weeks))
- Body composition and anthropometrics: Body mass index(Baseline, end of week 10)
- Muscle strength: Hand grip strenght(Baseline, end of week 10)
- Functional performance: Maximal gait speed(Baseline, end of week 10)
- Functional performance: Stair climb(Baseline, end of week 10)
- Blood pressure: Systolic blood pressure(Baseline, end of week 10)
- Blood pressure: Diastolic blood pressure(Baseline, end of week 10)
- 1 and 2-years over-all survival(Randomization to 1 and 2 years after randomization)
- Treatment tolerance: Number of series recieved(3, 6 and 9 weeks after randomization)
- Health-related quality of life: Physical well-being(Baseline, 10 weeks-, 1 year-, and 2 years after randomization)
- Health-related quality of life: cancer cachexia specific(Baseline, 10 weeks-, 1 year-, and 2 years after randomization)
- Depression(Baseline, 10 weeks-, 1 year-, and 2 years after randomization)
- Treatment effect: Response to chemotherapy(Randomization to 2 years after randomization)
- Treatment tolerance: Tolerated dose(3, 6 and 9 weeks after randomization)
- Treatment tolerance: Permanent discontinuation of the treatment(3, 6 and 9 weeks after randomization)
- Health-related quality of life: Functional well-being(Baseline,10 weeks-, 1 year-, 2 years after randomization)
- Self-reported physical activity: Moderate intensity physical activity (PA)(Baseline, end of week 10)
- Self-reported physical activity: Total PA(Baseline, end of week 10)
- Functional performance: Sit-to-stand(Baseline, end of week 10)
- Progression-free survival(Randomization to 2 years after randomization)
- Treatment tolerance: Hospitalization(3, 6 and 9 weeks after randomization)
- Treatment tolerance: Relative dose intensity(3, 6 and 9 weeks after randomization)
- Health-related quality of life: Emotional well-being(Baseline, 10 weeks-, 1 year-, and 2 years after randomization)
- Anxiety(Baseline, 10 weeks-, 1 year-, and 2 years after randomization)
- Self-reported physical activity: Walking(Baseline, end of week 10)
- Patient-reported symptomatic adverse events(One week after each serie of chemotherapy during the intervention (10 weeks))
- Self-reported physical activity: Vigorous intensity PA(Baseline, end of week 10)
- Self-reported screening of sarcopenia(Baseline, end of week 10)
- Self-reported three-days dietary records(Baseline, week 5 and week 10)
研究者
Rikke Krabek, MD
Principal Investigator
Rigshospitalet, Denmark