NCT01258478

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
390

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 13, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

December 13, 2010

Status Verified

December 1, 2010

Enrollment Period

3 years

First QC Date

December 7, 2010

Last Update Submit

December 10, 2010

Conditions

Non Small Cell Lung Cancer

Keywords

NSCLC, rehabilitation, CPET, lung resection

Outcome Measures

Primary Outcomes (1)

  • 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

    30 days after surgery

Secondary Outcomes (1)

  • All endpoints in primary outcomes, taken separately and others, mentioned below

    1 year

Study Arms (2)

rehabilitation

EXPERIMENTAL

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

Other: Rehabilitation

usual care

SHAM COMPARATOR

Usual care before surgery is provided

Other: Usual care

Interventions

RehabilitationOTHER

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

rehabilitation
Usual careOTHER

Usual care

usual care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Universitaires de Genève

Geneva, Canton of Geneva, 1211, Switzerland

RECRUITING

Related Publications (2)

  • 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.

    PMID: 28419206DERIVED

  • 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.

    PMID: 27771425DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Pierre-Olivier Bridevaux, MD, MSc

CONTACT

022/ 372 33 11pierre-olivier.bridevaux@hcuge.ch

Marc-Joseph Licker, MD, Professor

CONTACT

022-3818801Marc-Joseph.Licker@hcuge.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 7, 2010

First Posted

December 13, 2010

Study Start

December 1, 2010

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

December 13, 2010

Record last verified: 2010-12

Locations

CH(1)