Lung Cancer Rehabilitation Study

Not Applicable

• Conditions: Non Small Cell Lung Cancer
• Interventions: Other: Rehabilitation; Other: Usual care

• Registration Number: NCT01258478
• Lead Sponsor: University Hospital, Geneva

Brief Summary

Patients suffering from non small cell lung cancer(NSCLC), depend upon lung removal to increase their chances of survival. But, this type of surgery cannot be advised to patients with significant heart disease, limited lung fuction or reduced physical fitness. Intensive physical training has been shown to increase aerobic fitness in healthy subjects.

The purpose of this study is to determine the effect of a short term rehabilitation prior to surgery on the post-operative and physiological outcomes for patients undergoing this type of surgery.

Detailed Description

For patients with non small cell lung cancer (NSCLC), lung resection surgery is the only treatment option which increases survival. However, surgery can not be offered to those with significant heart disease, limited lung function or lacking physical fitness. These are all major risk factors for operative outcome. Cardio-pulmonary exercise testing (CPET) allows direct measurement of aerobic physical fitness through maximal oxygen consumption (VO2 max). A recent update of professional guidelines (ERS/ESTS) has emphasized the importance of CPET in preoperative risk stratification of patients with NSCLC. Interestingly, intensive physical training has been shown to increase aerobic fitness in animals and healthy subjects whereas improvement of VO2 max has been observed in preliminary pilot studies conducted in patients undergoing surgery for NSCLC. However, the net effect of short-term, intensive, outpatient rehabilitation on clinically relevant outcomes, such as major post-operative cardio-pulmonary complications, as well as physiological outcomes is unknown.

Objectives:

1. To assess the physiological effect of 3 weeks of intensive physical training in patients eligible for NSCLC surgery.

2. To assess the effect of physical training on post-operative outcomes.

3. To identify the clinical variables, laboratory tests and specific gene polymorphisms (SNPs) associated with these outcomes.

Study Timeline

• Status Verified: 2010-12
• Study Start: 2010-12
• Study First Submitted: 2010-12-07
• Study First Submitted QC: 2010-12-10
• Last Update Submitted: 2010-12-10
• Study First Posted: 2010-12-13
• Last Update Posted: 2010-12-13
• Primary Completion: 2013-12
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

Proven or suspected lung cancer, stage III A or less (eligible for surgical cure), documented by CT-scan or Positron Emission Tomography CT scan (PET-CT)

Exclusion Criteria

• Contra-indication to perform cardio-pulmonary exercise test (uncontrolled cardiac disease, severe pulmonary hypertension, osteo-articular limitations impeding cycling)
• Inability to adhere to rehabilitation program (because of clinically limiting comorbidity, psychiatric condition or osteoarthritis)
• Clinically limiting or untreated heart disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rehabilitation	Rehabilitation	Three weeks of outpatient, intensive physical rehabilitation before lung resection surgery.
usual care	Usual care	Usual care before surgery is provided

Primary Outcome Measures

Name	Time	Method
A composite endpoint of respiratory or cardiac or other post-operative complications requiring therapy	30 days after surgery	Respiratory Pneumonia Atelectasis (requiring bronchoscopy or positive expiratory pressure) Mechanical ventilation \>12 hours Unplanned re-intubation Acute lung injury or acute respiratory distress syndrome (ALI/ARDS) Cardiac Acute heart failure Myocardial infarction or acute coronary syndrome Arrhythmia Other Delirium, mental status changes Stroke or transient ischemic accident 30-day mortality Acute renal failure (doubling of baseline pre-operative value) Surgical site infection

Secondary Outcome Measures

Name	Time	Method
All endpoints in primary outcomes, taken separately and others, mentioned below	1 year	90 day mortality Hospital Length of stay, admission and re-admission in ICU Surgical wound infections Quality of life scores CPET and other physiological tests changes from baseline to week 3 Echocardiography changes from baseline to week 3, limited to those with high baseline NT-pro-BNP value (\>300 ug/L) or those with a Lee score ≥2 Non invasive measurement of tissue oxygenation using Near Infrared Spectroscopy (NIRS) Nutritional status changes from baseline to week 3 Smoking behaviour changes from baseline to week 3 Cardiac autonomic nervous control

Trial Locations

Locations (1)

Hôpitaux Universitaires de Genève; 🇨🇭 Geneva, Switzerland