Cardiopulmonary Exercise Testing in Lung Cancer Patients Before and During Oncological Treatment

April 7, 2026 updated by: Medical University of Bialystok

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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:

Baseline assessment: prior to the initiation of standard oncological treatment (either before planned surgery or before initiation of systemic therapy).

Follow-up assessment after the early phase of treatment: approximately 6 weeks (±1 week) after surgery or approximately 6-8 weeks (±2 weeks) after initiation of systemic therapy, depending on the clinical pathway and feasibility.

These time points are intended to capture baseline physiological reserve and early treatment-related changes in exercise capacity. The primary evaluation focuses on change in key CPET measures between baseline and follow-up.

Cardiopulmonary exercise testing (CPET) procedure CPET is conducted using a standardized incremental protocol on a cycle ergometer under continuous supervision by trained personnel, with full medical safety measures available. Prior to exercise, resting assessments include symptom review, vital signs, and baseline electrocardiographic monitoring. During CPET, respiratory gas exchange is measured breath-by-breath and standard hemodynamic and ventilatory variables are recorded throughout the test. Exercise intensity increases in a stepwise or ramp fashion until symptom-limited maximal effort, clinical indication to stop, or achievement of standard termination criteria. Perceived exertion and dyspnea are recorded using standardized scales. Recovery monitoring is continued after exercise completion until clinical stability is confirmed.

CPET parameters of interest Key CPET-derived variables include peak oxygen uptake (VO₂peak), anaerobic threshold, ventilatory efficiency indices (including the VE/VCO₂ relationship), and additional exploratory measures of ventilatory limitation and circulatory response as available from standard CPET output. These parameters are used to characterize cardiorespiratory reserve, identify potential exercise-limiting mechanisms, and evaluate within-subject changes over time.

Routine clinical data collection In addition to CPET, routinely collected clinical information is recorded for descriptive and exploratory analyses. This may include demographic data and clinical characteristics, smoking history, comorbidities (including cardiovascular disease and risk factors), performance status, anthropometric measures (height, weight, body mass index), resting oxygen saturation, standard pulmonary function tests (spirometry with bronchodilator testing, lung volumes/plethysmography where available, diffusing capacity), resting electrocardiography, and standard laboratory parameters commonly used in oncological qualification and monitoring. Imaging studies and cardiac assessments performed as part of routine care (e.g., computed tomography staging, echocardiography when clinically indicated) may be documented. The study does not mandate additional imaging or laboratory procedures beyond standard clinical practice.

Safety considerations CPET is performed in a controlled clinical environment and follows established safety standards. Participants are screened for contraindications prior to testing. Any adverse events related to testing are documented and managed according to institutional procedures. The study does not introduce therapeutic interventions, and participation does not alter the standard oncological treatment plan.

Study objectives The primary objective is to characterize baseline cardiorespiratory fitness and to evaluate early changes in exercise tolerance during standard oncological management in patients with lung cancer. Secondary objectives include identification of patients with reduced physiological reserve who may be at increased risk of exercise intolerance or clinical decompensation during treatment, and exploratory assessment of associations between CPET measures and routine clinical characteristics.

Potential significance By providing objective and repeatable measures of functional reserve, CPET-based assessment may support individualized monitoring in routine clinical care and may improve understanding of treatment-related functional changes in lung cancer patients.

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-276
        • Recruiting
        • University Clinical Hospital in Bialystok, II Department of Pulmonology, Lung Cancer and Internal Medicine, Medical University of Bialystok
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients (≥18 years) with histologically confirmed lung cancer (any stage) and WHO/ECOG performance status 0-2, treated with standard oncological management in a tertiary university hospital and undergoing cardiopulmonary exercise testing before treatment initiation and after the early phase of therapy or surgery.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: Cardiopulmonary Exercise Testing (CPET)
Symptom-limited cardiopulmonary exercise testing performed using a standardized incremental protocol on a cycle ergometer to assess integrated cardiorespiratory, ventilatory, and metabolic responses to exercise. The test is conducted under continuous medical supervision with electrocardiographic and blood pressure monitoring, in accordance with established safety guidelines and standard termination criteria.
Other Names:
  • CPET
  • Spiroergometry
  • Cardiopulmonary exercise test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in peak oxygen uptake (VO2peak) measured by cardiopulmonary exercise testing
Time Frame: 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.
Baseline and 6-8 weeks after treatment initiation or approximately 6 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in anaerobic threshold assessed by cardiopulmonary exercise testing
Time Frame: Baseline and 6-8 weeks after treatment initiation or approximately 6 weeks after surgery
Within-participant change in anaerobic threshold determined during cardiopulmonary exercise testing between baseline (before treatment initiation) and follow-up after the early phase of standard oncological therapy or surgery.
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
Time Frame: Baseline and 6-8 weeks after treatment initiation or approximately 6 weeks after surgery
Within-participant change in ventilatory efficiency expressed as the VE/VCO2 slope obtained during cardiopulmonary exercise testing at baseline and follow-up.
Baseline and 6-8 weeks after treatment initiation or approximately 6 weeks after surgery
Change in peak work rate during cardiopulmonary exercise testing
Time Frame: Baseline and 6-8 weeks after treatment initiation or approximately 6 weeks after surgery
Within-participant change in peak work rate (watts) achieved during cardiopulmonary exercise testing between baseline and follow-up.
Baseline and 6-8 weeks after treatment initiation or approximately 6 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Bialystok

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

April 7, 2026

First Submitted That Met QC Criteria

April 7, 2026

First Posted (Actual)

April 14, 2026

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APK.002.70.2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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