Clinical trial NCT01258478: Lung Cancer Rehabilitation Study
Official title: Short-Term Pre-operative Rehabilitation for Patients With Lung Cancer: A Randomized Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non Small Cell Lung Cancer
Keywords: NSCLC, rehabilitation, CPET, lung resection
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2010-12-13
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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

Primary outcomes:
measure: A composite endpoint of respiratory or cardiac or other post-operative complications requiring therapy
timeFrame: 30 days after surgery
Secondary outcomes:
measure: All endpoints in primary outcomes, taken separately and others, mentioned below
timeFrame: 1 year
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève
Study officials:
References:
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.
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.