Assessment of Respiratory Parameters and Physical Performance in Patients With Lung Cancer Qualified for Oncological Treatment Before and During Therapy, With Special Consideration of Cardiovascular Risk: A Cardiopulmonary Exercise Testing Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in peak oxygen uptake (VO2peak) measured by cardiopulmonary exercise testing
研究概览
简要总结
Patients with lung cancer often have reduced physical fitness and coexisting health problems, which may limit their ability to tolerate oncological treatment. Standard resting lung and heart tests do not always reflect real-life physical capacity during everyday activities or physical effort.
This observational study aims to assess cardiorespiratory fitness in patients with lung cancer before and during standard oncological treatment using cardiopulmonary exercise testing (CPET). CPET is a safe, supervised exercise test that provides objective information on how the heart, lungs, and muscles respond to physical effort.
Participants with WHO/ECOG performance status 0-2 will undergo CPET before treatment initiation and again after the early phase of therapy or surgery. The results may help identify patients with reduced physiological reserve and support individualized monitoring during routine clinical care.
详细描述
This prospective observational study assesses respiratory and exercise-related physiological parameters in adult patients with lung cancer who are qualified for standard oncological management, including surgical treatment and/or systemic therapy. Lung cancer patients frequently present with reduced functional capacity and relevant comorbidities, including cardiovascular risk factors, which may affect treatment tolerance. Resting pulmonary function tests and standard clinical assessments do not always reflect the integrated cardiorespiratory response to physical stress. Cardiopulmonary exercise testing (CPET) provides an objective and reproducible evaluation of the combined responses of the respiratory, cardiovascular, and metabolic systems during graded exercise.
The study is conducted in a tertiary university hospital setting. Patients are enrolled consecutively from routine clinical pathways. There is no assignment to any experimental intervention; all oncological treatments are delivered according to standard-of-care clinical decisions. CPET is the only study-specific procedure performed in addition to routine diagnostics and follow-up assessments. The planned enrollment is approximately 90 participants.
Study population and eligibility Eligible participants are adults (≥18 years) with histologically confirmed lung cancer (any stage) who are qualified for standard oncological management and have WHO/ECOG performance status 0-2. Written informed consent is required. Key safety-related exclusion criteria include unstable ischemic heart disease, symptomatic arrhythmias, myocarditis/pericarditis, decompensated heart failure, active deep vein thrombosis, suspected aortic dissection or severe aortic stenosis, poorly controlled asthma, resting oxygen saturation ≤85% on room air, clinically relevant treatment-related adverse events above mild intensity (as applicable), and withdrawal of consent.
Study assessments and timing
CPET is performed at two predefined time points for each participant:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18 years
- •Histologically confirmed lung cancer (any stage)
- •Qualified for standard oncological management (surgery and/or systemic therapy)
- •WHO/ECOG performance status 0-2
- •Ability to perform cardiopulmonary exercise testing (CPET)
- •Written informed consent
排除标准
- •Unstable ischemic heart disease
- •Symptomatic cardiac arrhythmias
- •Myocarditis or pericarditis
- •Decompensated heart failure
- •Active deep vein thrombosis
- •Suspected aortic dissection or severe aortic stenosis
- •Poorly controlled asthma
- •Resting oxygen saturation ≤ 85% on room air
- •Clinically relevant treatment-related adverse events above mild intensity (as applicable)
- •Any medical condition that, in the investigator's opinion, precludes safe participation in CPET
- •Withdrawal of informed consent
研究组 & 干预措施
Lung cancer cohort
Adult patients (≥18 years) with histologically confirmed lung cancer (any stage) and WHO/ECOG performance status 0-2, qualified for standard oncological management. Participants undergo cardiopulmonary exercise testing (CPET) at baseline (before treatment) and after the early phase of standard oncological therapy or surgery.
干预措施: Cardiopulmonary Exercise Testing (CPET) (Diagnostic Test)
结局指标
主要结局
Change in peak oxygen uptake (VO2peak) measured by cardiopulmonary exercise testing
时间窗: Baseline and 6-8 weeks after treatment initiation or approximately 6 weeks after surgery
Within-participant change in peak oxygen uptake (VO2peak, mL/kg/min) assessed during symptom-limited cardiopulmonary exercise testing at baseline (before treatment initiation) and at follow-up after the early phase of standard oncological therapy or surgery.
次要结局
- Change in anaerobic threshold assessed by cardiopulmonary exercise testing(Baseline and 6-8 weeks after treatment initiation or approximately 6 weeks after surgery)
- Change in ventilatory efficiency (VE/VCO2 slope) assessed by cardiopulmonary exercise testing(Baseline and 6-8 weeks after treatment initiation or approximately 6 weeks after surgery)
- Change in peak work rate during cardiopulmonary exercise testing(Baseline and 6-8 weeks after treatment initiation or approximately 6 weeks after surgery)