Overview

This trial is active, not recruiting.

Conditions lung cancer, perioperative/postoperative complications, pulmonary complications, tobacco use disorder
Treatments exercise intervention, smoking cessation intervention, counseling intervention, educational intervention, conventional surgery, pulmonary complications management/prevention
Phase phase 2
Sponsor Mayo Clinic
Collaborator National Cancer Institute (NCI)
Start date August 2006
End date September 2016
Trial size 90 participants
Trial identifier NCT00363428, 08-007135, K23CA106544, MC0825, NCI-2009-01148, P30CA047904

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Placebo Comparator)
Receive standard care and educational material on exercise and lifestyle choices of well-being
exercise intervention
life style
smoking cessation intervention
Life style
counseling intervention
life style
educational intervention
life style
conventional surgery
life style
pulmonary complications management/prevention
life style
(Experimental)
exercise intervention
life style
smoking cessation intervention
Life style
counseling intervention
life style
educational intervention
life style
conventional surgery
life style
pulmonary complications management/prevention
life style

Primary Outcomes

Measure
Length of stay in hospital and functional status measured at 12 weeks post-operatively
time frame: 12 weeks

Secondary Outcomes

Measure
Hospital re-admission
time frame: 12 months
Oxygen requirement
time frame: 12 months
Post-operative pulmonary function
time frame: 12 months
Respiratory care interventions
time frame: 12 months
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
Measured physical activity at 6 months
time frame: 12 months

Eligibility Criteria

Male or female participants from 40 years up to 120 years old.

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

Additional Information

Official title A Randomized Trial of Pulmonary Rehabilitation in Patients With Moderate to Severe COPD Who Require Lung Resection for Lung Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.