Lung Cancer Rehabilitation Study — LCRS  

Non Small Cell Lung Cancer Clinical Trial

Official title: Short-Term Pre-operative Rehabilitation for Patients With Lung Cancer: A Randomized Trial.

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

• NCT number: NCT01258478
• Study type: Interventional
• Source: University Hospital, Geneva
• Contact: Pierre-Olivier Bridevaux, MD, MSc
• Phone: 022/ 372 33 11
• Email: pierre-olivier.bridevaux@hcuge.ch
• Status: Recruiting
• Phase: N/A
• Start date: December 2010
• Completion date: January 2014