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

Lung Cancer Clinical Trial

Official title:

A Randomized Trial of Pulmonary Rehabilitation in Patients With Moderate to Severe COPD Who Require Lung Resection for Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00363428
• Other study ID #: MC0825
• Secondary ID: P30CA047904K23CA
• Status: Completed
• Phase: N/A
• First received: August 10, 2006
• Last updated: July 17, 2017
• Start date: August 2006
• Est. completion date: November 1, 2012

Study information

• Verified date: July 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: November 1, 2012
• Est. primary completion date: November 1, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Perioperative/Postoperative Complications
• Postoperative Complications
• Pulmonary Complications
• Pulmonary Disease, Chronic Obstructive
• Tobacco Use Disorder

Intervention

Behavioral:
• exercise intervention
life style
• smoking cessation intervention
Life style

Other:
• counseling intervention
life style
• educational intervention
life style

Procedure:
• conventional surgery
life style
• pulmonary complications management/prevention
life style

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay in hospital and functional status measured at 12 weeks post-operatively		12 weeks
Secondary	Hospital re-admission		12 months
Secondary	Oxygen requirement		12 months
Secondary	Post-operative pulmonary function		12 months
Secondary	Respiratory care interventions		12 months
Secondary	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
Secondary	Measured physical activity at 6 months		12 months