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Lung Cancer Rehabilitation Study (LCRS)

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ClinicalTrials.gov Identifier: NCT01258478
Recruitment Status : Unknown
Verified December 2010 by University Hospital, Geneva.
Recruitment status was:  Recruiting
First Posted : December 13, 2010
Last Update Posted : December 13, 2010
Sponsor:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment
Non Small Cell Lung Cancer Other: Rehabilitation Other: Usual care

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Short-Term Pre-operative Rehabilitation for Patients With Lung Cancer: A Randomized Trial.
Study Start Date : December 2010
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. A composite endpoint of respiratory or cardiac or other post-operative complications requiring therapy [ Time Frame: 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 :
  1. All endpoints in primary outcomes, taken separately and others, mentioned below [ Time Frame: 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


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01258478


Contacts
Contact: Pierre-Olivier Bridevaux, MD, MSc 022/ 372 33 11 pierre-olivier.bridevaux@hcuge.ch
Contact: Marc-Joseph Licker, MD, Professor 022-3818801 ext 7958552 Marc-Joseph.Licker@hcuge.ch

Locations
Switzerland
Hôpitaux Universitaires de Genève Recruiting
Geneva, Switzerland, 1211
Principal Investigator: Pierre-Olivier Bridevaux, MD, MSc         
Sponsors and Collaborators
University Hospital, Geneva
More Information

Responsible Party: Dr. Pierre-Olivier Bridevaux, University Hospital Geneva
ClinicalTrials.gov Identifier: NCT01258478     History of Changes
Other Study ID Numbers: Protocole 09-263
First Posted: December 13, 2010    Key Record Dates
Last Update Posted: December 13, 2010
Last Verified: December 2010

Keywords provided by University Hospital, Geneva:
NSCLC, rehabilitation, CPET, lung resection

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms