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Pulmonary Rehabilitation for Lung Cancer
Phase 2
Waitlist Available
Led By Vickie Shannon, BS,MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Must not have
Active psychiatric illness that could interfere with treatment
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether pulmonary rehabilitation can help people with poor lung function become eligible for surgery, and whether it improves health after surgery.
Who is the study for?
This trial is for lung cancer patients who can't have surgery due to poor lung function or other health issues but are otherwise stable. They should be able to perform some exercise without severe heart problems, not have bone metastasis, severe pulmonary hypertension, serious heart failure, or active psychiatric illness that could interfere.
What is being tested?
The study is testing if a program of pulmonary rehabilitation (special exercises and therapies for the lungs) before surgery can improve lung function enough to make patients eligible for surgery and help them recover better after the operation.
What are the potential side effects?
Pulmonary rehabilitation generally has minimal side effects but may include muscle soreness and fatigue. The questionnaire poses no physical risks but might cause emotional discomfort if sensitive topics are discussed.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung function tests show I can't have surgery for my lung tumor.
Select...
I am considered not fit for surgery due to my limited ability to perform daily activities.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have a psychiatric condition that could affect my treatment.
Select...
I have severe lung blood pressure or heart issues related to lung disease.
Select...
I have had fainting, chest pain, irregular heartbeat, or a significant drop in blood pressure during exercise.
Select...
I have severe heart failure that medication can't manage, with an LVEF under 40%.
Select...
My cancer has spread to my bones.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pulmonary RehabilitationExperimental Treatment2 Interventions
Pulmonary Rehabilitation - Rehabilitation treatment given over about 3-4 weeks. Questionnaire regarding quality-of-life that lasts about 30 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pulmonary Rehabilitation
2011
Completed Phase 4
~1640
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,272 Total Patients Enrolled
Vickie Shannon, BS,MDPrincipal InvestigatorM.D. Anderson Cancer Center