Lung CancerPhase 2NCT00618553
Effect of Pulmonary Rehabilitation on Surgical Outcomes in the Cancer Setting
A Phase 2 study testing Questionnaire and Pulmonary Rehabilitation in people with Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Questionnaire and Pulmonary Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2008to 1 Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: The Efficacy of Pulmonary Rehabilitation in Improving Surgical Eligibility for Lung Resection
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.
Read the 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:
If you choose to take part in this study, you will have 3-4 weeks of pulmonary rehabilitation. During the 3-4 week period, you will have 9-12 study visits that will last about 90 minutes each. The following tests and procedures will be performed:
6-Minute Walk Test:
To perform the 6-minute walk test, you will walk as far as possible around cones on a flat indoor course that is about 40 yards long. You will walk at your own pace and can take breaks at any time. After 6 minutes, the study staff will check the total distance you have walked. Your vital signs (blood pressure, heart rate, temperature, and breathing rate) will be measured before and after the walk. Your oxygen saturation levels will be monitored throughout the test. You will wear a small clip on your finger that will send the oxygen saturation data to a small computer.
Oxygen Consumption Test:
An oxygen consumption study will help the doctor determine how well your heart and lungs work while you exercise. You will be asked to pedal on a bicycle that does not move, while wearing a mouthpiece to measure the amount of oxygen you take in. Wires will be placed on your chest to monitor your heart activity, and a blood pressure cuff will be placed on your arm to monitor your blood pressure.
The amount of exercise you can do will be measured by increasing the resistance you pedal against. You should continue pedaling until you become short of breath or too tired to keep going. You may stop exercising at any time if you become very uncomfortable or experience dizziness, chest pains, and/or shortness of breath.
During or after the oxygen consumption test, blood (about 2 teaspoons) may be drawn to measure the amount of oxygen in your blood.
If you live outside of the Houston area, you will be referred to a pulmonary rehabilitation program in your local area. Any records from the outside pulmonary rehabilitation facility will be given to the study staff after the study is completed. You will have your follow-up visits (described below) at M. D. Anderson.
Follow-up Visits:
Your health status will be checked at 1 and 3 months after your last study visit if you do not have surgery, or 1 and 3 months after your surgery. At these follow-up visits, the following tests and procedures will be performed:
- You will have a 6-minute walk test, a Pulmonary Function Test, and an Oxygen Consumption Test.
- You will be asked to fill out a quality-of-life questionnaire that should take about 30 minutes to complete.
- You will be asked how well you are able to perform the normal activities of daily living (performance status evaluation).
- An echocardiogram will be done on a patient-by patient basis. An echocardiogram uses sound waves to make pictures of your heart, which helps show how well your heart pumps blood. You will be asked to lie on your left side while a technician places a probe with gel on your chest to create images of your heart to determine the function and size.
Long-term Follow-up:
The research staff may contact you by phone regarding your health status. Patients who have lung surgery may be contacted by phone or have their medical records reviewed during the course of 30 days after surgery or during hospitalization for surgery (hospitalization may last more than 30 days).
This is an investigational study. Using pulmonary rehabilitation to try to improve patients' lung function is considered experimental. At this time, it is being done in research only. Up to 75 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Lung Cancer
- Being tested
- Questionnaire, Pulmonary Rehabilitation
- Keywords
- Lung Cancer, Pulmonary Rehabilitation, Questionnaire, Survey, Lung Function, Quality of Life
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Also called Survey
Questionnaire regarding quality-of-life that lasts about 30 minutes.
Pulmonary RehabilitationBehavioural
Rehabilitation treatment given over about 3-4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Rehabilitation | Experimental | Pulmonary Rehabilitation - Rehabilitation treatment given over about 3-4 weeks. Questionnaire regarding quality-of-life that lasts about 30 minutes. Receives: Other: Questionnaire; Behavioral: Pulmonary Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Success (conversion from ineligible to eligible status for lung resection following Pulmonary rehabilitation (PR))
Measured: Baseline and post treatment (following 3-4 weeks of PR)
Secondary outcomes (1)
Examine health of pulmonary rehabilitation participants after surgery.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study start28 Jan 2008
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vickie Shannon, BS,MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00618553
- Sponsor's protocol ID
- 2007-0063
- Other IDs
- NCI-2012-01749
- Status last verified
- Jul 2026
- First submitted
- 28 Jan 2008
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Pulmonary Rehabilitation in Improving Surgical Eligibility for Lung Resection
- ClinicalTrials.gov ID
- NCT00618553
- Acronym / sponsor ID
- 2007-0063
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, Pulmonary Rehabilitation, Questionnaire, Survey, Lung Function, Quality of Life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 28 Jan 2008 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 20 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
If you choose to take part in this study, you will have 3-4 weeks of pulmonary rehabilitation. During the 3-4 week period, you will have 9-12 study visits that will last about 90 minutes each. The following tests and procedures will be performed:
6-Minute Walk Test:
To perform the 6-minute walk test, you will walk as far as possible around cones on a flat indoor course that is about 40 yards long. You will walk at your own pace and can take breaks at any time. After 6 minutes, the study staff will check the total distance you have walked. Your vital signs (blood pressure, heart rate, temperature, and breathing rate) will be measured before and after the walk. Your oxygen saturation levels will be monitored throughout the test. You will wear a small clip on your finger that will send the oxygen saturation data to a small computer.
Oxygen Consumption Test:
An oxygen consumption study will help the doctor determine how well your heart and lungs work while you exercise. You will be asked to pedal on a bicycle that does not move, while wearing a mouthpiece to measure the amount of oxygen you take in. Wires will be placed on your chest to monitor your heart activity, and a blood pressure cuff will be placed on your arm to monitor your blood pressure.
The amount of exercise you can do will be measured by increasing the resistance you pedal against. You should continue pedaling until you become short of breath or too tired to keep going. You may stop exercising at any time if you become very uncomfortable or experience dizziness, chest pains, and/or shortness of breath.
During or after the oxygen consumption test, blood (about 2 teaspoons) may be drawn to measure the amount of oxygen in your blood.
If you live outside of the Houston area, you will be referred to a pulmonary rehabilitation program in your local area. Any records from the outside pulmonary rehabilitation facility will be given to the study staff after the study is completed. You will have your follow-up visits (described below) at M. D. Anderson.
Follow-up Visits:
Your health status will be checked at 1 and 3 months after your last study visit if you do not have surgery, or 1 and 3 months after your surgery. At these follow-up visits, the following tests and procedures will be performed:
- You will have a 6-minute walk test, a Pulmonary Function Test, and an Oxygen Consumption Test.
- You will be asked to fill out a quality-of-life questionnaire that should take about 30 minutes to complete.
- You will be asked how well you are able to perform the normal activities of daily living (performance status evaluation).
- An echocardiogram will be done on a patient-by patient basis. An echocardiogram uses sound waves to make pictures of your heart, which helps show how well your heart pumps blood. You will be asked to lie on your left side while a technician places a probe with gel on your chest to create images of your heart to determine the function and size.
Long-term Follow-up:
The research staff may contact you by phone regarding your health status. Patients who have lung surgery may be contacted by phone or have their medical records reviewed during the course of 30 days after surgery or during hospitalization for surgery (hospitalization may last more than 30 days).
This is an investigational study. Using pulmonary rehabilitation to try to improve patients' lung function is considered experimental. At this time, it is being done in research only. Up to 75 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Rehabilitation | Experimental | Other: Questionnaire, Behavioral: Pulmonary RehabilitationPulmonary Rehabilitation - Rehabilitation treatment given over about 3-4 weeks. Questionnaire regarding quality-of-life that lasts about 30 minutes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAlso: SurveyQuestionnaire regarding quality-of-life that lasts about 30 minutes. | Other | Pulmonary Rehabilitation |
| Pulmonary RehabilitationRehabilitation treatment given over about 3-4 weeks. | Behavioural | Pulmonary Rehabilitation |
Primary outcome
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)
1 secondary outcome
Examine health of pulmonary rehabilitation participants after surgery.
Time frame: 2 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vickie Shannon, BS,MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Questionnaire and Pulmonary Rehabilitation in people with Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.