Simplified Exercise-based Risk Assessment in Lung Cancer

NCT07506889 | Not Yet Recruiting

• 1 other identifier: 2025-05681-01
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

End-Tidal Carbon Dioxide; Exercise; Lung Cancer (Diagnosis); Lobectomy; Surgery Complications; Neoadjuvant Chemoimmunotherapy

Outcome Measures

Primary Outcomes (1)

• Major cardiopulmonary complications following lung cancer lobectomy

  Any of the following within 90 days of surgery: * Respiratory failure requiring intervention (continuous positive airway pressure, non-invasive ventilation, high flow oxygen therapy or re-intubation) * Pneumonia: Patient has received antibiotics for a suspected respiratory infection and met one of the following criteria: (a) new or changed sputum, (b) new or changed lung opacities, (c) fever, (d) white blood cell count \<4 × 109/L or \>12 × 109/L, (e) C-reactive protein \>20 * Pulmonary embolus: verified with computed tomography pulmonary angiography or pulmonary scintigraphy * Atelectasis requiring bronchoscopy * Empyema * Delayed extubation (not able to extubate same day as surgery) * Reoperation * chest drainage \>5 days post-operatively * new chest drainage post-operatively, * oxygen treatment after post-operative day 0, * non-fatal cardiac arrest * acute myocardial infarction, * angina pectoris, * stroke, * Death by any cause

  90 days

Secondary Outcomes (5)

• Major cardiopulmonary complications following sublobular resection for lung cancer

  90 days

• Two-year mortality following lung cancer surgery

  2 years

• Severe adverse effects in primary systemic therapy in lung cancer

  90 days

• Severe side-effects in neoadjuvant treatment for lung cancer

  90 days or start of primary treatment

• Length of hospital stay after surgical treatment for lung cancer

  90 days

Study Arms (4)

Primary objective cohort - Lung cancer lobectomy

For primary objective, patients undergoing lobectomy for lung cancer will be studied.

Neoadjuvant treatment cohort

As one secondary objective, patients with lung cancer undergoing neoadjuvant treatment before surgery or other non-surgical treatment will be studied separately

Sub-lobular resection cohort

As one secondary objective, patients undergoing sublobular resection for lung cancer will be studied separately.

Non-surgical treatment cohort

As one secondary objective, patients undergoing other treatment than surgery for lung cancer will be studied.

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

Patients referred for suspected lung cancer to one out of five Department of Pulmonology in Sweden will be asked to participate in study. Patients will perform a low-workload exercise test with measurement of end-tidal carbon dioxide with a handheld equipment. Patients in who further work-up dimiss lung cancer diagnosis will be excluded.

You may qualify if:

• Lung Cancer Diagnosis
• Age of at least 18 years

You may not qualify if:

• Not able to perform cycle ergometer exercise
• Not able to understand spoken or written Swedish

Sponsors & Collaborators

• Linkoeping University: lead
• Region Östergötland: collaborator
• Region Blekinge: collaborator
• Region Jönköping County: collaborator
• Region Skåne: collaborator
• Region Kalmar län: collaborator

Study Sites (5)

Department of Pulmonology, Ryhov

Jönköping, Sweden

Location

Department of Pulmonology, Kalmar County Hospital

Kalmar, Sweden

Location

Department of Pulmonology, Blekinge Hospital

Karlskrona, Sweden

Location

Department of Pulmonology, University Hospital

Linköping, Sweden

Location

Department of Clinical Physiology

Lund, Sweden

Location

MeSH Terms

Conditions

Lung Neoplasms; Disease; Motor Activity

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Kristofer Hedman, MD, PhD

  Department of Medical, Health and Caring Sciences, Linkoping University, Linkoping, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristofer Hedman, MD, PhD

CONTACT

+46 10 1033356; kristofer.hedman@liu.se

Karolina Kristenson

CONTACT

karolina.kristenson@regionostergotland.se

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Associate Professor

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 2, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

SE (5)