Lung Cancer Clinical Trial; Lung Rehabilitation in Treating Patients With Chronic Obstructive Pulmonary Disease Who Are Undergoing Surgery for Lung Cancer

Lung Rehabilitation in Treating Patients With Chronic Obstructive Pulmonary Disease Who Are Undergoing Surgery for Lung Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2007
Sponsors and Collaborators: UPMC Cancer Centers
National Cancer Institute (NCI)

Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00363428

Purpose
RATIONALE: Exercise may help improve lung function and lessen complications of surgery in patients with chronic obstructive pulmonary disease who are undergoing surgery for lung cancer. It is not yet known whether lung rehabilitation is more effective than standard therapy in improving lung function in patients with chronic obstructive pulmonary disease who are undergoing surgery for lung cancer.

PURPOSE: This randomized clinical trial is studying lung rehabilitation to see how well it works compared to standard therapy in treating patients with chronic obstructive pulmonary disease who are undergoing surgery for lung cancer.

Condition Intervention
Cancer-Related Problem/Condition
Lung Cancer
Behavioral: exercise intervention
Behavioral: smoking cessation intervention
Other: counseling
Other: educational intervention
Procedure: conventional surgery
Procedure: pulmonary complications management/prevention

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Cancer Exercise and Physical Fitness Lung Cancer Rehabilitation Surgery
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Single Blind
Official Title: A Randomized Trial of Pulmonary Rehabilitation in Patients With Moderate to Severe COPD Who Require Lung Resection for Lung Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
Length of stay in hospital measured in days

Duration of mechanical ventilation measured in hours

Duration of Intensive Care Unit stay measured in days

Incidence of postoperative pulmonary complications

Change in spirometry values, 6-minute walk test, maximal oxygen consumption, health status, and dyspnea measurements at 3 months after hospital discharge

Estimated Enrollment: 120
Study Start Date: August 2006
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Detailed Description:
OBJECTIVES:

Primary

Compare the impact of preoperative pulmonary rehabilitation (including upper and lower extremity resistance training) vs usual care in patients with lung cancer and moderate to severe chronic obstructive pulmonary disease who require lung resection for lung cancer.
Compare the impact of this study intervention vs usual care on functional status after surgery.
OUTLINE: This is a randomized, multicenter, single-blind study. Patients are randomized to 1 of 2 intervention arms.

Arm I: Patients undergo pulmonary rehabilitation (including daily upper and lower extremity resistance training, education, and smoking cessation counseling) for 4 weeks prior to surgical resection.
Arm II: Patients receive usual care (education and smoking cessation counseling alone) for 4 weeks prior to surgical resection.
Duration of postoperative mechanical ventilation, postoperative complications (i.e., pneumonia, respiratory failure, adult respiratory distress syndrome, or atelectasis requiring bronchoscopy) and days of hospitalization will be evaluated after surgery.

After study completion, patients will be followed for 5 years.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Eligibility

Ages Eligible for Study: 40 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria
DISEASE CHARACTERISTICS:

Diagnosis of lung cancer requiring lung resection
Current or former smoker
Spirometry must demonstrate moderate to severe airway obstruction defined by all of the following:

FEV_1/FVC < 70
FEV_1 < 70% of predicted (prior to bronchodilation)
PATIENT CHARACTERISTICS:

No cardiovascular or musculoskeletal problems prohibiting study intervention
PRIOR CONCURRENT THERAPY:

Not specified
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363428

Locations
United States, Pennsylvania
UPMC Cancer Centers Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Clinical Trials Office - UPMC Cancer Centers 412-647-8073
UPMC - Shadyside Recruiting
Pittsburgh, Pennsylvania, United States, 15213-2582
Contact: Clinical Trials Office - UPMC - Shadyside 412-621-2334

Sponsors and Collaborators
UPMC Cancer Centers
National Cancer Institute (NCI)
Investigators
Study Chair: Roberto P. Benzo, MD, MS UPMC Cancer Centers

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers: CDR0000491312, PCI-0603002
Study First Received: August 10, 2006
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00363428 [history]
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
pulmonary complications
perioperative/postoperative complications
tobacco use disorder
non-small cell lung cancer
small cell lung cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Small Cell
Non-small cell lung cancer
Lung Diseases, Obstructive
Respiratory Tract Diseases
Postoperative Complications
Lung Neoplasms
Tobacco Use Disorder
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:
Neoplasms by Site
Respiratory Tract Neoplasms
Neoplasms

ClinicalTrials.gov processed this record on February 10, 2009

Back to top of Main Content

U.S. National Library of Medicine, Contact Help Desk
U.S. National Institutes of Health, U.S. Department of Health & Human Services,
USA.gov, Copyright, Privacy, Accessibility, Freedom of Information Act