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

NCT07529145 | Recruiting

• 1 other identifier: APK.002.70.2025
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-Small Cell Carcinoma of Lung; Small Cell Carcinoma of Lung

Keywords

lung cancer treatment; cpet; V02peak; ventilatory efficiency; cardiopulmonary exercise testing

Outcome Measures

Primary Outcomes (1)

• Change in peak oxygen uptake (VO2peak) measured by cardiopulmonary exercise testing

  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 Outcomes (3)

• 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

Study Arms (1)

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)

Interventions

Cardiopulmonary Exercise Testing (CPET) DIAGNOSTIC_TEST

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.

Also known as: CPET, Spiroergometry, Cardiopulmonary exercise test

Lung cancer cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Bialystok: lead

Study Sites (1)

University Clinical Hospital in Bialystok, II Department of Pulmonology, Lung Cancer and Internal Medicine, Medical University of Bialystok

Bialystok, Podlaskie Voivodeship, 15-276, Poland

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Central Study Contacts

Klaudia Jadczak, Medical Doctor

CONTACT

+48608726832; klaudia.jadczak@sd.umb.edu.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)