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

Primary Purpose

Lung Cancer, Perioperative/Postoperative Complications, Pulmonary Complications

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
exercise intervention
smoking cessation intervention
counseling intervention
educational intervention
conventional surgery
pulmonary complications management/prevention
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer focused on measuring pulmonary complications, perioperative/postoperative complications, tobacco use disorder, non-small cell lung cancer, small cell lung cancer

Eligibility Criteria

40 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Lifestyle intervention

Arm Description

Receive standard care and educational material on exercise and lifestyle choices of well-being

Outcomes

Primary Outcome Measures

Length of stay in hospital and functional status measured at 12 weeks post-operatively

Secondary Outcome Measures

Hospital re-admission
Oxygen requirement
Post-operative pulmonary function
Respiratory care interventions
Number and percentage of patients with postoperative complications (defined as pneumonia, mechanical ventilation of more than 2 days, or atelectasis requiring a bronchoscopy)
Measured physical activity at 6 months

Full Information

First Posted
August 10, 2006
Last Updated
July 17, 2017
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00363428
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 2006 (Actual)
Primary Completion Date
November 1, 2012 (Actual)
Study Completion Date
November 1, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Perioperative/Postoperative Complications, Pulmonary Complications, Tobacco Use Disorder
Keywords
pulmonary complications, perioperative/postoperative complications, tobacco use disorder, non-small cell lung cancer, small cell lung cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Receive standard care and educational material on exercise and lifestyle choices of well-being
Arm Title
Lifestyle intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
exercise intervention
Intervention Description
life style
Intervention Type
Behavioral
Intervention Name(s)
smoking cessation intervention
Intervention Description
Life style
Intervention Type
Other
Intervention Name(s)
counseling intervention
Intervention Description
life style
Intervention Type
Other
Intervention Name(s)
educational intervention
Intervention Description
life style
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Description
life style
Intervention Type
Procedure
Intervention Name(s)
pulmonary complications management/prevention
Intervention Description
life style
Primary Outcome Measure Information:
Title
Length of stay in hospital and functional status measured at 12 weeks post-operatively
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Hospital re-admission
Time Frame
12 months
Title
Oxygen requirement
Time Frame
12 months
Title
Post-operative pulmonary function
Time Frame
12 months
Title
Respiratory care interventions
Time Frame
12 months
Title
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
Title
Measured physical activity at 6 months
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto P. Benzo, MD, MS
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31618297
Citation
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.
Results Reference
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Lung Rehabilitation in Treating Patients With Chronic Obstructive Pulmonary Disease Who Are Undergoing Surgery for Lung Cancer

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