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

Official Title: “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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Control
  • Receive standard care and educational material on exercise and lifestyle choices of well-being
• Experimental: Lifestyle intervention

Primary Measures

• Length of stay in hospital and functional status measured at 12 weeks post-operatively
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Hospital re-admission
  • Time Frame: 12 months
    Safety Issue?: Yes
• Oxygen requirement
  • Time Frame: 12 months
    Safety Issue?: No
• Post-operative pulmonary function
  • Time Frame: 12 months
    Safety Issue?: No
• Respiratory care interventions
  • Time Frame: 12 months
    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
    Safety Issue?: Yes
• Measured physical activity at 6 months
  • Time Frame: 12 months
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Mayo Clinic Other

Overall Clinical Trial Officials and Contacts

Roberto P. Benzo, MD, MS Study Chair Mayo Clinic  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00363428

Study ID Number: CDR0000491312

ClinicalTrials.gov Identifier: NCT00363428

Health Authority: United States: Federal Government

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