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

18 Years
Open (Enrolling)
Non Small Cell Lung Cancer

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Trial Information

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

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.


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.

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

Type of Study:


Study Design:

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

Outcome Measure:

A composite endpoint of respiratory or cardiac or other post-operative complications requiring therapy

Outcome 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

Outcome Time Frame:

30 days after surgery

Safety Issue:



Switzerland: Commission Centrale d'éthique

Study ID:

Protocole 09-263



Start Date:

December 2010

Completion Date:

January 2014

Related Keywords:

  • Non Small Cell Lung Cancer
  • NSCLC, rehabilitation, CPET, lung resection
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms