Clinical Trial

Simplified Exercise-based Risk Assessment in Lung Cancer

Study acronym: EXHALE-CO2
Not Yet Recruiting
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Summary
Physiological evaluation is part of the preoperative risk estimation in patients with lung cancer, and it aids in the choice of treatment. Ventilatory efficiency during exercise has emerged as a strong predictor of major postoperative complications, so far determined during a maximal cardiopulmonary exercise test. However, this test is limited by its availability and high cost, due to the requirement of high-technological equipment and advanced expertise. The current project aims to evaluate a simplified and accessible method for risk evaluation before decision on treatment in lung cancer. It builds on recent advances in technology and knowledge and combines a simple, low-intensity cycling test with measurement of ventilatory efficiency (end-tidal carbon dioxide pressure) with a handheld monitor. In a prospective, multi-center design the investigators will include patients evaluated for suspected lung cancer. The main objective is to establish threshold values for end-tidal carbon dioxide associated with low respectively high risk of major complications in patients undergoing surgery. In addition, the study aims to determine if end-tidal carbon dioxide can predict severe side-effects during neoadjuvant or curatively aiming systemic therapy. The project is closely linked to clinical practice, and the results can be easily implemented due to the simple and cost-efficient methodology. the suggested simplified approach would also allow access to physiological evaluation where more advanced methods are unavailable.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-03-26.
Trial Details
NCT Number NCT07506889
Lead Sponsor Linkoeping University
Collaborators: Region Östergötland, Region Skane, Region Kalmar län, Region Blekinge, Region Jönköping County
Conditions Lung Cancer (Diagnosis), Lobectomy, Surgery Complications, Neoadjuvant Chemoimmunotherapy, End-Tidal Carbon Dioxide, Exercise
Enrollment 500 participants
Start Date 2026-04-01
Primary Completion 2029-12 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-08