Effect of Pulmonary Rehabilitation on Surgical Outcomes in the Cancer Setting - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00618553

Purpose

Primary Objectives:

To determine whether pulmonary rehabilitation improves surgical candidacy, among patients who are deemed ineligible for surgery because of poor performance status (2 or 3) and/or impaired lung function FEV1 ppo <40% pred: DLCO ppo <40% pred and/or VO2 peak < 60% predicted.
To determine whether pulmonary rehabilitation improves surgical treatment outcomes, which includes improvements in secondary outcome measures such as dyspnea scores, fatigue scores, exercise capacity (6MWT = 12% increase in distance walked), ECOG score (improved to 1 or 2), health care utilization (decrease in post operative complications), and survival will also be monitored and used to assess the success of the program.

Condition	Intervention	Phase
Lung Cancer	Other: Questionnaire Behavioral: Pulmonary Rehabilitation	Phase II

MedlinePlus related topics: Cancer Lung Cancer Rehabilitation Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	The Efficacy of Pulmonary Rehabilitation in Improving Surgical Eligibility for Lung Resection

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To see if pulmonary rehabilitation can improve patients' lung function, which would increase their chances of becoming eligible for surgery. [ Time Frame: 2 Years ] [ 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 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Pulmonary Rehabilitation	Other: Questionnaire Questionnaire regarding quality-of-life that lasts about 30 minutes. 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
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00618553

Contacts

Contact: Vickie Shannon, MD, BS

713-563-4254

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Vickie Shannon, MD, BS

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Vickie Shannon, MD, BS

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Vickie Shannon,MD, BS /Professor )
Study ID Numbers:	2007-0063
Study First Received:	January 28, 2008
Last Updated:	March 17, 2009
ClinicalTrials.gov Identifier:	NCT00618553 History of Changes
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

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Quality of Life

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

ClinicalTrials.gov processed this record on May 07, 2009