Lung Cancer Rehabilitation Study (LCRS)

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

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.

Study Overview

• Status: Unknown
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Other: Usual care; Other: Rehabilitation

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 Type: Interventional
• Enrollment (Anticipated): 390
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pierre-Olivier Bridevaux, MD, MSc; Phone Number: 022/ 372 33 11; Email: pierre-olivier.bridevaux@hcuge.ch
• Study Contact Backup: Name: Marc-Joseph Licker, MD, Professor; Phone Number: 7958552 022-3818801; Email: Marc-Joseph.Licker@hcuge.ch

Study Locations

• Switzerland
  • Geneva, Switzerland, 1211
    • Recruiting
    • Hôpitaux universitaires de Genève
    • Principal Investigator: Pierre-Olivier Bridevaux, MD, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rehabilitation; Three weeks of outpatient, intensive physical rehabilitation before lung resection surgery.	Other: Rehabilitation; Three weeks of outpatient, intensive physical rehabilitation before lung resection surgery.
Sham Comparator: usual care; Usual care before surgery is provided	Other: Usual care; Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A composite endpoint of respiratory or cardiac or other post-operative complications requiring therapy	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	30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All endpoints in primary outcomes, taken separately and others, mentioned below	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	1 year

Collaborators and Investigators

• Sponsor: University Hospital, Geneva

Publications and helpful links

General Publications

• Karenovics W, Licker M, Ellenberger C, Christodoulou M, Diaper J, Bhatia C, Robert J, Bridevaux PO, Triponez F. Short-term preoperative exercise therapy does not improve long-term outcome after lung cancer surgery: a randomized controlled study. Eur J Cardiothorac Surg. 2017 Jul 1;52(1):47-54. doi: 10.1093/ejcts/ezx030.
• Licker M, Karenovics W, Diaper J, Fresard I, Triponez F, Ellenberger C, Schorer R, Kayser B, Bridevaux PO. Short-Term Preoperative High-Intensity Interval Training in Patients Awaiting Lung Cancer Surgery: A Randomized Controlled Trial. J Thorac Oncol. 2017 Feb;12(2):323-333. doi: 10.1016/j.jtho.2016.09.125. Epub 2016 Oct 19.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): January 1, 2014

Study Registration Dates

• First Submitted: December 7, 2010
• First Submitted That Met QC Criteria: December 10, 2010
• First Posted (Estimate): December 13, 2010

Study Record Updates

• Last Update Posted (Estimate): December 13, 2010
• Last Update Submitted That Met QC Criteria: December 10, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: NSCLC, rehabilitation, CPET, lung resection
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: Protocole 09-263