Lung Cancer Rehabilitation Study (LCRS)
Primary Purpose
Non Small Cell Lung Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Rehabilitation
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring NSCLC, rehabilitation, CPET, lung resection
Eligibility 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
Sites / Locations
- Hôpitaux Universitaires de GenèveRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
rehabilitation
usual care
Arm Description
Three weeks of outpatient, intensive physical rehabilitation before lung resection surgery.
Usual care before surgery is provided
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01258478
First Posted
December 7, 2010
Last Updated
December 10, 2010
Sponsor
University Hospital, Geneva
1. Study Identification
Unique Protocol Identification Number
NCT01258478
Brief Title
Lung Cancer Rehabilitation Study
Acronym
LCRS
Official Title
Short-Term Pre-operative Rehabilitation for Patients With Lung Cancer: A Randomized Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
January 2014 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Geneva
4. Oversight
Data Monitoring Committee
No
5. 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.
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:
To assess the physiological effect of 3 weeks of intensive physical training in patients eligible for NSCLC surgery.
To assess the effect of physical training on post-operative outcomes.
To identify the clinical variables, laboratory tests and specific gene polymorphisms (SNPs) associated with these outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
NSCLC, rehabilitation, CPET, lung resection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
390 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
rehabilitation
Arm Type
Experimental
Arm Description
Three weeks of outpatient, intensive physical rehabilitation before lung resection surgery.
Arm Title
usual care
Arm Type
Sham Comparator
Arm Description
Usual care before surgery is provided
Intervention Type
Other
Intervention Name(s)
Rehabilitation
Intervention Description
Three weeks of outpatient, intensive physical rehabilitation before lung resection surgery.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Usual care
Primary Outcome Measure Information:
Title
A composite endpoint of respiratory or cardiac or other post-operative complications requiring therapy
Description
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
Time Frame
30 days after surgery
Secondary Outcome Measure Information:
Title
All endpoints in primary outcomes, taken separately and others, mentioned below
Description
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
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre-Olivier Bridevaux, MD, MSc
Phone
022/ 372 33 11
Email
pierre-olivier.bridevaux@hcuge.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Marc-Joseph Licker, MD, Professor
Phone
022-3818801
Ext
7958552
Email
Marc-Joseph.Licker@hcuge.ch
Facility Information:
Facility Name
Hôpitaux Universitaires de Genève
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre-Olivier Bridevaux, MD, MSc
12. IPD Sharing Statement
Citations:
PubMed Identifier
28419206
Citation
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.
Results Reference
derived
PubMed Identifier
27771425
Citation
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.
Results Reference
derived
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Lung Cancer Rehabilitation Study
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