Effect of Pulmonary Rehabilitation on Surgical Outcomes in the Cancer Setting

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00618553
First received: January 28, 2008
Last updated: November 5, 2013
Last verified: November 2013
  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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: November 5, 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 August 21, 2014