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Lung Cancer Rehabilitation Study

NCT ID: NCT01258478

Last Updated: 2010-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2014-01-31

Brief Summary

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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

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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.

Conditions

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Non Small Cell Lung Cancer

Keywords

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NSCLC, rehabilitation, CPET, lung resection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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rehabilitation

Three weeks of outpatient, intensive physical rehabilitation before lung resection surgery.

Group Type EXPERIMENTAL

Rehabilitation

Intervention Type OTHER

Three weeks of outpatient, intensive physical rehabilitation before lung resection surgery.

usual care

Usual care before surgery is provided

Group Type SHAM_COMPARATOR

Usual care

Intervention Type OTHER

Usual care

Interventions

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Rehabilitation

Three weeks of outpatient, intensive physical rehabilitation before lung resection surgery.

Intervention Type OTHER

Usual care

Usual care

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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University Hospital Geneva

Locations

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Hôpitaux Universitaires de Genève

Geneva, Canton of Geneva, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Pierre-Olivier Bridevaux, MD, MSc

Role: CONTACT

Phone: 022/ 372 33 11

Email: [email protected]

Marc-Joseph Licker, MD, Professor

Role: CONTACT

Phone: 022-3818801

Email: [email protected]

References

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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.

Reference Type DERIVED
PMID: 28419206 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27771425 (View on PubMed)

Other Identifiers

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Protocole 09-263

Identifier Type: -

Identifier Source: org_study_id