Simplified Exercise-based Risk Assessment in Lung Cancer

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLinkoeping University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Lung Cancer Diagnosis

Age of at least 18 years

Disqualifiers

Not able to perform cycle ergometer exercise

Not able to understand spoken or written Swedish

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

500 Participants
are grouped into 4 trial groups
Group A: Primary objective cohort - Lung cancer lobectomy
Group B: Neoadjuvant treatment cohort
Group C: Sub-lobular resection cohort
Group D: Non-surgical treatment cohort

Trial outcomes

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

Time frame
90 days

Secondary outcomes

1

Major cardiopulmonary complications following sublobular resection for lung cancer

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

Time frame
90 days
2

Two-year mortality following lung cancer surgery

Death by any cause following lung cancer surgery

Time frame
2 years
3

Severe adverse effects in primary systemic therapy in lung cancer

In patients with lung cancer not undergoing surgery, any severe side-effect defined as grade III to V according to Common Terminoly of Adverse Events (CTAEA version 5) as any of the following: 1. Severe or medically significant but not immedialetly life-threatening; hospitalization or prolongation of hospitalization is indicated, disabling, limiting self-care (grade III), 2. Life-threatening consequences: urgent intervention indicated (grade IV) or 3. death related to an adverse event

Time frame
90 days
4

Severe side-effects in neoadjuvant treatment for lung cancer

In patients with lung cancer undergoing neoadjuvant treatment before surgery or non-surgival treatment, any severe side-effect defined as grade III to V according to Common Terminoly of Adverse Events (CTAEA version 5) as any of the following: 1. Severe or medically significant but not immedialetly life-threatening; hospitalization or prolongation of hospitalization is indicated, disabling, limiting self-care (grade III), 2. Life-threatening consequences: urgent intervention indicated (grade IV) or 3. death related to an adverse event

Time frame
90 days or start of primary treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Linkoeping University

Lead sponsor

Region Östergötland

Collaborator

Region Skane

Collaborator

Region Kalmar län

Collaborator

Region Blekinge

Collaborator

Region Jönköping County

Collaborator

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