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

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

Official Title
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A Randomized Trial Assessing the Effects of Exercise on Patients With Locally Advanced Lung Cancer Undergoing Curative Intent Combined Modality Therapy

Conditions
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Lung Cancer, Pulmonary Complications

Intervention / Treatment
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* Other: educational intervention
* Other: supervised exercise program


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age Not specified Performance status Zubrod 0-2 Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Cardiovascular No acute EKG changes, arrhythmia, or other cardiac abnormality that would preclude study participation No uncontrolled cardiac disease No recent myocardial infarction Pulmonary Any FEV_1 level by pulmonary function testing Other 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 PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics Endocrine therapy Not specified Radiotherapy See Disease Characteristics Surgery Not specified
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 12-week exercise program + education<br>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<br> <br> Other: supervised exercise program<br> <br> |
| Other: Education<br>At the time of enrollment patients are provided educational materials focusing on breathing and energy conservation. | Other: educational intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise tolerance | comparison between the control and intervention arms in the percent change in the 6-minute walk distance between baseline and 6 months. | Baseline and at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life | The difference in total score between pre-study and 6 months for the FACT-L Quality of Life measure. | Baseline and at 6 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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