Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00363428
First received: August 10, 2006
Last updated: March 24, 2014
Last verified: March 2014
  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 Phase
Lung Cancer
Perioperative/Postoperative Complications
Pulmonary Complications
Tobacco Use Disorder
Behavioral: exercise intervention
Behavioral: smoking cessation intervention
Other: counseling intervention
Other: educational intervention
Procedure: conventional surgery
Procedure: pulmonary complications management/prevention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomized Trial of Pulmonary Rehabilitation in Patients With Moderate to Severe COPD Who Require Lung Resection for Lung Cancer

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Length of stay in hospital and functional status measured at 12 weeks post-operatively [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospital re-admission [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Oxygen requirement [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Post-operative pulmonary function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Respiratory care interventions [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number and percentage of patients with postoperative complications (defined as pneumonia, mechanical ventilation of more than 2 days, or atelectasis requiring a bronchoscopy) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Measured physical activity at 6 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: August 2006
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
Receive standard care and educational material on exercise and lifestyle choices of well-being
Behavioral: exercise intervention
life style
Behavioral: smoking cessation intervention
Life style
Other: counseling intervention
life style
Other: educational intervention
life style
Procedure: conventional surgery
life style
Procedure: pulmonary complications management/prevention
life style
Experimental: Lifestyle intervention Behavioral: exercise intervention
life style
Behavioral: smoking cessation intervention
Life style
Other: counseling intervention
life style
Other: educational intervention
life style
Procedure: conventional surgery
life style
Procedure: pulmonary complications management/prevention
life style

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 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) twice a day for 5 days prior to surgical resection. Beginning 2-3days after surgery, patients undergo pulmonary rehabilitation once a day until discharge from the hospital.
  • Arm II: Patients receive usual care (education and smoking cessation counseling alone) twice a day for 5 days prior to surgical resection. Following surgery, patients will receive usual care once a day until discharge from the hospital.

Days of hospitalization, ICU admissions, postoperative complications (i.e., pneumonia, mechanical ventilation > 48 hours, or atelectasis requiring bronchoscopy) and spirometry and imaging studies will be evaluated after surgery.

After completion of study intervention, patients are followed at 4-6 weeks, at 12 weeks, and at 6 months.

PROJECTED ACCRUAL: A total of 90 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
  • Scheduled to undergo any thoracotomy for lung cancer resection (including wedge) or VATS lobectomy or pneumonectomy for lung resection
  • Diagnosis of COPD, meeting the following criteria:

    • FEV_1/FVC < 0.71
    • Smoking history ≥ 10 pack/years
  • Presence of moderate to severe lung disease, meeting 1 of the following:

    • FEV_1 ≤ 60% predicted*
    • FEV_1< 80% predicted AND significant shortness of breath defined by a score of 2 or higher in the Medical Research Council Dyspnea Score NOTE: *Patients with an FEV1 < 60% predicted (most severe) and scheduled to undergo VATS segmentectomy or wedge resection will also be included.

PATIENT CHARACTERISTICS:

  • Able to physically utilize exercise equipment as part of rehabilitation program
  • No poor motivation or likely not to participate fully in PR program
  • No recent history (within the past 3 months) of a clinically-significant myocardial infarction, unstable angina, serious cardiac arrhythmia, or other serious medical condition which the attending physician performing the preoperative evaluation deems incompatible with participation in the study

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Roberto P. Benzo, MD, MS Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Roberto P. Benzo, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00363428     History of Changes
Other Study ID Numbers: MC0825, P30CA047904, K23CA106544, 08-007135, NCI-2009-01148, MC0825
Study First Received: August 10, 2006
Last Updated: March 24, 2014
Health Authority: United States: Federal Government

Keywords provided by Mayo Clinic:
pulmonary complications
perioperative/postoperative complications
tobacco use disorder
non-small cell lung cancer
small cell lung cancer

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Lung Neoplasms
Postoperative Complications
Pulmonary Disease, Chronic Obstructive
Tobacco Use Disorder
Chemically-Induced Disorders
Lung Diseases
Mental Disorders
Neoplasms
Neoplasms by Site
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Substance-Related Disorders
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014