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

August 10, 2006
March 24, 2014
August 2006
September 2014   (final data collection date for primary outcome measure)
Length of stay in hospital and functional status measured at 12 weeks post-operatively [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00363428 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Lung Rehabilitation in Treating Patients With Chronic Obstructive Pulmonary Disease Who Are Undergoing Surgery for Lung Cancer
A Randomized Trial of Pulmonary Rehabilitation in Patients With Moderate to Severe COPD Who Require Lung Resection for Lung Cancer

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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Lung Cancer
  • Perioperative/Postoperative Complications
  • Pulmonary Complications
  • Tobacco Use Disorder
  • 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
  • Placebo Comparator: Control
    Receive standard care and educational material on exercise and lifestyle choices of well-being
    Interventions:
    • Behavioral: exercise intervention
    • Behavioral: smoking cessation intervention
    • Other: counseling intervention
    • Other: educational intervention
    • Procedure: conventional surgery
    • Procedure: pulmonary complications management/prevention
  • Experimental: Lifestyle intervention
    Interventions:
    • Behavioral: exercise intervention
    • Behavioral: smoking cessation intervention
    • Other: counseling intervention
    • Other: educational intervention
    • Procedure: conventional surgery
    • Procedure: pulmonary complications management/prevention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
90
Not Provided
September 2014   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00363428
MC0825, P30CA047904, K23CA106544, 08-007135, NCI-2009-01148, MC0825
Yes
Roberto P. Benzo, M.D., Mayo Clinic Cancer Center
Mayo Clinic
National Cancer Institute (NCI)
Study Chair: Roberto P. Benzo, MD, MS Mayo Clinic
Mayo Clinic
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP