NCT00618553

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for phase_2 lung-cancer

Timeline
29mo left

Started Jan 2008

Longer than P75 for phase_2 lung-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Jan 2008Sep 2028

First Submitted

Initial submission to the registry

January 28, 2008

Completed
Same day until next milestone

Study Start

First participant enrolled

January 28, 2008

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 20, 2008

Completed
20.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

20.6 years

First QC Date

January 28, 2008

Last Update Submit

January 9, 2026

Conditions

Keywords

Lung CancerPulmonary RehabilitationQuestionnaireSurveyLung FunctionQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Treatment Success (conversion from ineligible to eligible status for lung resection following Pulmonary rehabilitation (PR))

    Baseline and post treatment (following 3-4 weeks of PR)

Secondary Outcomes (1)

  • Examine health of pulmonary rehabilitation participants after surgery.

    2 Years

Study Arms (1)

Pulmonary Rehabilitation

EXPERIMENTAL

Pulmonary Rehabilitation - Rehabilitation treatment given over about 3-4 weeks. Questionnaire regarding quality-of-life that lasts about 30 minutes.

Other: QuestionnaireBehavioral: Pulmonary Rehabilitation

Interventions

Questionnaire regarding quality-of-life that lasts about 30 minutes.

Also known as: Survey
Pulmonary Rehabilitation

Rehabilitation treatment given over about 3-4 weeks.

Pulmonary Rehabilitation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Vickie Shannon, BS,MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2008

First Posted

February 20, 2008

Study Start

January 28, 2008

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

January 12, 2026

Record last verified: 2026-01

Locations