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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 April 2013 |
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Main ID: |
NCT00618553 |
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Date of registration:
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28/01/2008 |
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Primary sponsor: |
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Public title:
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Effect of Pulmonary Rehabilitation on Surgical Outcomes in the Cancer Setting
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Scientific title:
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The Efficacy of Pulmonary Rehabilitation in Improving Surgical Eligibility for Lung Resection |
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Date of first enrolment:
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January 2008 |
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Target sample size:
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75 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00618553 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Vickie Shannon, MD, BS |
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Address:
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Telephone:
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Email:
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Affiliation:
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M.D. Anderson Cancer Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. 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.
2. Patients deemed surgically inoperable based on poor performance status (ECOG score
2-3)
3. Any non-pulmonary co-morbidity must be stable according to institutional guidelines.
Exclusion Criteria:
1. 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)
2. Previously reported exercise-induced syncope, angina, palpitation, arrhythmia,
hypotension (drop of 20% of systolic/dystolic from baseline)
3. History of severe congestive heart failure (NYHA class 3 and 4) refractory to medical
management, (LVEF < 40% by echocardiogram).
4. Bone metastasis
5. Active psychiatric illness that could interfere with treatment.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lung Cancer
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Intervention(s)
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Behavioral: Pulmonary Rehabilitation
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Other: Questionnaire
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Primary Outcome(s)
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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)]
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Secondary Outcome(s)
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Examine health of pulmonary rehabilitation participants after surgery.
[Time Frame: 2 Years]
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Secondary ID(s)
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2007-0063
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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