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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder; Lung Cancer; Perioperative/Postoperative Complications; Pulmonary Complications
• Intervention / Treatment: Behavioral: exercise intervention; Behavioral: smoking cessation intervention; Other: counseling intervention; Other: educational intervention; Procedure: conventional surgery; Procedure: pulmonary complications management/prevention

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Length of stay in hospital and functional status measured at 12 weeks post-operatively	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Hospital re-admission	12 months
Oxygen requirement	12 months
Post-operative pulmonary function	12 months
Respiratory care interventions	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)	12 months
Measured physical activity at 6 months	12 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Roberto P. Benzo, MD, MS, Mayo Clinic

Publications and helpful links

General Publications

• Perrotta F, Cennamo A, Cerqua FS, Stefanelli F, Bianco A, Musella S, Rispoli M, Salvi R, Meoli I. Effects of a high-intensity pulmonary rehabilitation program on the minute ventilation/carbon dioxide output slope during exercise in a cohort of patients with COPD undergoing lung resection for non-small cell lung cancer. J Bras Pneumol. 2019 Oct 14;45(6):e20180132. doi: 10.1590/1806-3713/e20180132. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2006
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: August 10, 2006
• First Submitted That Met QC Criteria: August 10, 2006
• First Posted (Estimate): August 15, 2006

Study Record Updates

• Last Update Posted (Actual): July 19, 2017
• Last Update Submitted That Met QC Criteria: July 17, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: non-small cell lung cancer; small cell lung cancer; perioperative/postoperative complications; pulmonary complications; tobacco use disorder
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Substance-Related Disorders; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Tobacco Use Disorder; Postoperative Complications
• Other Study ID Numbers: MC0825 (Other Identifier: Mayo Clinic Cancer Center); P30CA047904 (U.S. NIH Grant/Contract); K23CA106544 (U.S. NIH Grant/Contract); 08-007135 (Other Identifier: Mayo Clinic IRB); NCI-2009-01148 (Registry Identifier: NCI-CTRP)