The Efficacy of Pulmonary Rehabilitation in Improving Surgical Eligibility for Lung Resection
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Treatment Success (conversion from ineligible to eligible status for lung resection following Pulmonary rehabilitation (PR))
Study Overview
Brief Summary
The goal of this clinical research study is to see if pulmonary rehabilitation can improve patients' lung function, which would increase their chances of becoming eligible for surgery. The health of pulmonary rehabilitation participants after surgery will also be examined.
Detailed Description
Pulmonary rehabilitation is a process that is designed to improve patients' lung function, muscular conditioning, exercise performance, and overall quality of life.
Study activities include exercise training, patient and family education, and psychosocial and behavioral counseling provided by a healthcare team.
Rehabilitation plans will vary patient by patient based on the results of the following tests:
- Blood (1-3 tablespoons) will be drawn for routine tests.
- You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart).
- You will have an X-ray of your chest.
- You will have a Pulmonary Function Test. For this test, you will be asked to breathe in several different ways while you have a mouthpiece in your mouth to test your lung function.
Study Visits:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with anatomically resectable lung tumors who are deemed surgically inoperable based on preoperative pulmonary function testing FEV1 < 80% pred; DLCO < 80% pred; FEV1ppo < 40% pred; DLCO ppo < 40% pred AND VO2 peak < 60% predicted or < 15 ml/kg/min.
- •Patients deemed surgically inoperable based on poor performance status (ECOG score 2-3)
- •Any non-pulmonary co-morbidity must be stable according to institutional guidelines.
Exclusion Criteria
- •Previously reported severe pulmonary hypertension (pulmonary artery systolic pressure > 60 as determined by echocardiogram), refractory cor pulmonale (as manifested by right ventricular dilatation or dysfunction by echocardiogram)
- •Previously reported exercise-induced syncope, angina, palpitation, arrhythmia, hypotension (drop of 20% of systolic/diastolic from baseline)
- •History of severe congestive heart failure (NYHA class 3 and 4) refractory to medical management, (LVEF < 40% by echocardiogram).
- •Bone metastasis
- •Active psychiatric illness that could interfere with treatment.
Arms & Interventions
Pulmonary Rehabilitation
Pulmonary Rehabilitation - Rehabilitation treatment given over about 3-4 weeks. Questionnaire regarding quality-of-life that lasts about 30 minutes.
Intervention: Questionnaire (Other)
Pulmonary Rehabilitation
Pulmonary Rehabilitation - Rehabilitation treatment given over about 3-4 weeks. Questionnaire regarding quality-of-life that lasts about 30 minutes.
Intervention: Pulmonary Rehabilitation (Behavioral)
Outcomes
Primary Outcomes
Treatment Success (conversion from ineligible to eligible status for lung resection following Pulmonary rehabilitation (PR))
Time Frame: Baseline and post treatment (following 3-4 weeks of PR)
Secondary Outcomes
- Examine health of pulmonary rehabilitation participants after surgery.(2 Years)