Better Symptom Control With Exercise in Patients With Advanced Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Maximum oxygen uptake (VO2 peak [ml/min/kg])
研究概览
简要总结
Lung cancer is one of the most common types of cancer in Germany, with 56,839 new cases and 45,072 deaths annually. Approximately 70% of patients with non-small cell lung cancer (NSCLC) are diagnosed at an advanced stage and suffer from comorbidities and symptoms such as fatigue, tiredness, and loss of strength. The standard first-line treatment for metastatic NSCLC includes platinum-based chemoimmunotherapy followed by immunotherapy maintenance. Exercise can have positive effects on symptoms such as shortness of breath, fatigue, quality of life, and physical fitness. However, there is a lack of current scientific evidence for the effectiveness of exercise in advanced lung cancer patients. No current trial investigated exercise in advanced NSCLC receiving immunotherapy so far.
The BREATH-study is a prospective 3-arm randomized controlled trial (RCT). In total, the investigators plan to recruit 104 patients. A 2:1:1 randomization will be performed with three study groups: a control group and two exercise therapy groups (strength+endurance exercise/only endurance exercise). One group receives individual endurance training and the other group a combination of individual endurance and strength training. Both treatment groups will be treated twice a week for 12 weeks. The control group will initially receive standard treatment without exercise for 12 weeks and will then be randomized into one of the other two study groups with exercise twice a week for 12 weeks. This approach allows for a sufficiently large sample for comparisons between exercise therapy and the control group, as well as between the two exercise therapy approaches.
The primary aim is to investigate the impact of exercise on V02peak. Secondarily endpoints aim to investigate changes in physical function, patient related outcomes and cardiac function before and after exercise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Patients with histologically confirmed non-small cell lung carcinoma in UICC stages IIIB and IV
- •First- or second-line therapy (inclusion up to 28 days after the first cycle) in palliative intention
- •Age ≥ 18 years
- •Signed informed consent
排除标准
- •Severe cardiopulmonary disease (EF<30%)
- •Newly occurring or progressive uncontrolled CNS (central nervous system) metastases
- •Expected life expectancy < 3 months
- •Bone metastases with acute risk of fracture
- •ECOG (Eastern Cooperative Oncology Group) performance status > 2
- •Acute pulmonary embolism
- •Acute myocardial infarction
- •Requiring surgery for aortic aneurysm
- •Tension pneumothorax
- •Lack of proficiency in the German language
- •Active infection
结局指标
主要结局
Maximum oxygen uptake (VO2 peak [ml/min/kg])
时间窗: assessed at Baseline, after 12 weeks and 24 weeks of enrolment
The primary goal is to achieve an improvement in performance (VO2 peak\[ml/min/kg\]) from T0 (enrolment) to T1 (12 weeks) through exercise compared to the standard treatment. The one-sided alternative hypothesis of a larger improvement in the two treatment groups compared to the control group will be tested statistically as a confirmatory analysis.
次要结局
- Leukocytes(Up to 24 weeks)
- High sensitive troponin I(Up to 24 weeks)
- Drop-out rate(Through study completion, an average of 12 weeks)
- Lymphocytes(Up to 24 weeks)
- Blood gas analysis pH value(assessed at baseline, after 12 weeks and 24 weeks of enrolment)
- Blood gas analysis (PAO2)(assessed at baseline, after 12 weeks and 24 weeks of enrolment)
- Blood gas analysis (SBCe)(assessed at baseline, after 12 weeks and 24 weeks of enrolment)
- CYRFRA 21-1(Up to 24 weeks)
- Arterial blood pressure(assessed at Baseline, after 12 weeks and 24 weeks of enrolment)
- Serious Adverse Event/Adverse Events(Through study completion, an average of 12 weeks)
- Treatment scheme(assessed at baseline after 12 weeks and 24 weeks of enrolment)
- NT-pro-BNP(Up to 24 weeks)
- Functional Assessment of Chronic Illness Therapy - Fatigue (FACT-F)(assessed at baseline, after 12 weeks and 24 weeks of enrolment)
- European Organisation for Research and Treatment of Cancer Lung cancer module (EORTC-LC13)(assessed at baseline, after 12 weeks and 24 weeks of enrolment)
- Change in ECG(assessed at baseline, after 12 weeks and 24 weeks of enrolment)
- Adherence to exercise intervention(Through study completion, an average of 12 weeks)
- Recruitment rate(At Baseline)
- Therapy response(Baseline and after 12 weeks)
- Erythrocytes(Up to 24 weeks)
- Neutrophils(Up to 24 weeks)
- CRP(Up to 24 weeks)
- Blood gas analysis (SaO2)(assessed at baseline, after 12 weeks and 24 weeks of enrolment)
- Blood gas analysis (BE)(assessed at baseline, after 12 weeks and 24 weeks of enrolment)
- European Organisation for Research and Treatment of Cancer (EORTC QLQ C30)(assessed at baseline after 12 weeks and 24 weeks of enrolment)
- Treatment Toxicity(assessed at baseline after 12 weeks and 24 weeks of enrolment)
- Hemoglobin(Up to 24 weeks)
- Physical function (Hypothetical One-repetition maximum)(assessed at baseline after 12 weeks and 24 weeks of enrolment)
- Blood gas analysis (PCO2)(assessed at baseline, after 12 weeks and 24 weeks of enrolment)
- Blood gas analysis (HCO3)(assessed at baseline, after 12 weeks and 24 weeks of enrolment)