Effect of Pulmonary Rehabilitation on Surgical Outcomes in the Cancer Setting
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00618553
First received: January 28, 2008
Last updated: April 2, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Other: Questionnaire Behavioral: Pulmonary Rehabilitation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Efficacy of Pulmonary Rehabilitation in Improving Surgical Eligibility for Lung Resection |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- 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) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Examine health of pulmonary rehabilitation participants after surgery. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 75 |
| Study Start Date: | January 2008 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Pulmonary Rehabilitation
Pulmonary Rehabilitation - Rehabilitation treatment given over about 3-4 weeks. Questionnaire regarding quality-of-life that lasts about 30 minutes.
|
Other: Questionnaire
Questionnaire regarding quality-of-life that lasts about 30 minutes.
Other Name: Survey
Behavioral: Pulmonary Rehabilitation
Rehabilitation treatment given over about 3-4 weeks.
|
Show Detailed Description Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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/dystolic 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00618553
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Vickie Shannon, MD, BS | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00618553 History of Changes |
| Other Study ID Numbers: | 2007-0063 |
| Study First Received: | January 28, 2008 |
| Last Updated: | April 2, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Lung Cancer Pulmonary Rehabilitation Questionnaire |
Survey Lung Function Quality of Life |
Additional relevant MeSH terms:
|
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 23, 2013