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Effect of Pulmonary Rehabilitation on Surgical Outcomes in the Cancer Setting

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00618553
First Posted: February 20, 2008
Last Update Posted: August 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  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: Intervention Model: Single Group Assignment
Masking: None (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) ]

Secondary Outcome Measures:
  • Examine health of pulmonary rehabilitation participants after surgery. [ Time Frame: 2 Years ]

Estimated Enrollment: 75
Actual Study Start Date: January 2008
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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/diastolic 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00618553


Locations
United States, Texas
University of Texas 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:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00618553     History of Changes
Other Study ID Numbers: 2007-0063
NCI-2012-01749 ( Registry Identifier: NCI CTRP )
First Submitted: January 28, 2008
First Posted: February 20, 2008
Last Update Posted: August 4, 2017
Last Verified: August 2017

Keywords provided by M.D. Anderson Cancer Center:
Lung Cancer
Pulmonary Rehabilitation
Questionnaire
Survey
Lung Function
Quality of Life