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S0229, Pulmonary Rehabilitation Education w/wo Exercise Training in Improving Physical Function in Patients Who Are Undergoing Chemo & RT for Locally Advanced Lung Cancer

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. Identifier: NCT00090961
Recruitment Status : Terminated (Closed early due to poor accrual.)
First Posted : September 8, 2004
Last Update Posted : November 1, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Brief Summary:

RATIONALE: Pulmonary rehabilitation education and exercise training may improve physical function and quality of life in patients who are receiving treatment for lung cancer.

PURPOSE: This randomized clinical trial is studying pulmonary rehabilitation education and exercise training to see how well they work compared to exercise training alone in improving physical function and quality of life in patients who are undergoing chemotherapy and radiation therapy for locally advanced lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Pulmonary Complications Other: educational intervention Other: supervised exercise program Not Applicable

Detailed Description:


  • Compare improvement in physiologic function, in terms of exercise tolerance, in patients with inoperable locally advanced lung cancer undergoing chemoradiotherapy and randomized to pulmonary rehabilitation comprising education with vs without supervised exercise training.
  • Compare the health-related quality of life, in terms of multidimensional functioning and patient perception of respiratory difficulties, in patients undergoing these pulmonary rehabilitation interventions.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Zubrod performance status (0-1 vs 2); FEV_1 (≥ 70% of predicted vs < 70% of predicted); and smoking status* (never smoked or former smoker vs current smoker). Approximately 20 weeks into treatment on SWOG-S0023, patients are randomized to 1 of 2 intervention arms.

NOTE: * Never smoked is defined as < 100 cigarettes in a lifetime and former smoker is defined as no smoking for ≥ 1 year.

  • Arm I: Patients participate in a supervised structured exercise program (i.e., walking on a treadmill OR using a stationary exercise bicycle) 3 times a week for 12 weeks. Patients also receive educational materials on how to improve breathing and conserve energy.
  • Arm II: Patients receive educational materials as in arm I. In both arms, patients undergo exercise testing using 6-minute walks to measure exercise tolerance at initial evaluation (after randomization but prior to intervention), 12 weeks, and then at 6 and 9 months.

In both arms, intervention continues in the absence of disease progression or the development of other medical conditions that would preclude study participation.

Quality of life is assessed at baseline, 12 weeks, and then at 6 and 9 months.

PROJECTED ACCRUAL: A total of 164 patients (82 per treatment arm) will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Randomized Trial Assessing the Effects of Exercise on Patients With Locally Advanced Lung Cancer Undergoing Curative Intent Combined Modality Therapy
Study Start Date : September 2004
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Arm Intervention/treatment
Experimental: 12-week exercise program + education
A 12-week supervised exercise program consisting of 3 days a week on a stationary bike or treadmill. In addition, at the time of enrollment patients are provided educational materials focusing on breathing and energy conservation.
Other: educational intervention
Other: supervised exercise program
At the time of enrollment patients are provided educational materials focusing on breathing and energy conservation.
Other: educational intervention

Primary Outcome Measures :
  1. Exercise tolerance [ Time Frame: Baseline and at 6 months ]
    comparison between the control and intervention arms in the percent change in the 6-minute walk distance between baseline and 6 months.

Secondary Outcome Measures :
  1. Health-related quality of life [ Time Frame: Baseline and at 6 months. ]
    The difference in total score between pre-study and 6 months for the FACT-L Quality of Life measure.

Information from the National Library of Medicine

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


  • Histologically or cytologically confirmed single, primary bronchogenic lung cancer

    • Inoperable, locally advanced disease (unresectable stage IIIA OR stage IIIB disease)
  • The following histologies are eligible:

    • Adenocarcinoma
    • Large cell carcinoma
    • Squamous cell carcinoma
    • Non-lobar and non-diffuse bronchoalveolar carcinoma
    • Small cell lung cancer
  • Must have received chemotherapy (platinum based) and radiotherapy for locally advanced unresectable lung cancer

    • Must have achieved a complete response, partial response, or stable disease after treatment



  • Not specified

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • No acute EKG changes, arrhythmia, or other cardiac abnormality that would preclude study participation
  • No uncontrolled cardiac disease
  • No recent myocardial infarction


  • Any FEV_1 level by pulmonary function testing


  • Willing to participate in 12-week long exercise program
  • Chemotherapy-induced neuropathy ≤ grade 2
  • No uncontrolled diabetes mellitus
  • No other medical condition that would preclude study participation


Biologic therapy

  • Not specified


  • See Disease Characteristics

Endocrine therapy

  • Not specified


  • See Disease Characteristics


  • Not specified

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 identifier (NCT number): NCT00090961

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Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
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Study Chair: Antoinette J. Wozniak, MD Barbara Ann Karmanos Cancer Institute
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Responsible Party: Southwest Oncology Group Identifier: NCT00090961    
Other Study ID Numbers: CDR0000380928
U10CA012027 ( U.S. NIH Grant/Contract )
First Posted: September 8, 2004    Key Record Dates
Last Update Posted: November 1, 2012
Last Verified: October 2012
Keywords provided by Southwest Oncology Group:
pulmonary complications
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
squamous cell lung cancer
large cell lung cancer
adenocarcinoma of the lung
bronchoalveolar cell lung cancer
limited stage small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases