Pulmonary Rehabilitation in Improving Lung Function in Patients With Locally Advanced Non-Small Cell Lung Cancer Undergoing Chemoradiation

Study Overview
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Brief Summary
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This randomized clinical trial studies pulmonary rehabilitation in improving lung function in patients with locally advanced non-small cell lung cancer undergoing chemoradiation. Individualized exercise rehabilitation programs may reduce breathing problems and improve quality of life in patients with non-small cell lung cancer. It is not yet known whether pulmonary rehabilitation is more effective when started during or after cancer treatment.

Detailed Description
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PRIMARY OBJECTIVES: I. To determine feasibility of pulmonary rehabilitation (PR) in patients with locally advanced unresectable non-small cell lung cancer (NSCLC) undergoing definite chemotherapy and radiation therapy. II. To measure exercise capacity and respiratory symptoms in lung cancer patients receiving chemotherapy and radiation before and after pulmonary rehabilitation. III. To compare if there are any differences in symptom relief, exercise capacity, and cancer treatment tolerability between performing pulmonary rehabilitation during chemo-radiation versus after completion of lung cancer treatment. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Beginning within 2 weeks of starting chemoradiation, patients undergo an individualized rehabilitation program comprising aerobic exercise and strength training, including treadmill walking, stationary bicycle, NU-Step, upper body resistance training and breathing retraining, 3 times per week for 8 weeks (36 sessions). ARM II: Beginning 1 month after completion of chemoradiation, patients undergo an individualized exercise rehabilitation program as in Arm I.

Official Title
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Pulmonary Rehabilitation in Locally Advanced Non-Small Cell Lung Cancer

Conditions
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Cachexia, Fatigue, Pulmonary Complications, Radiation Toxicity, Recurrent Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

Intervention / Treatment
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* Behavioral: exercise intervention
* Procedure: pulmonary complications management/prevention
* Procedure: quality-of-life assessment
* Other: questionnaire administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have been diagnosed with locally advanced unresectable NSCLC undergoing definite chemo-radiation with curative intent Patients must be able to sign informed consent Patients who qualify for pulmonary rehabilitation as part of the standard of care and are covered by medical insurance Patients must be able to ambulate a minimum of 100 feet prior to enrollment in pulmonary rehab Patients must be willing and able to travel to the pulmonary rehabilitation site at the Morehouse Medical Plaza Exclusion Criteria: Tumor resection candidates If survival is deemed less than 6 months for any medical condition If they have angina or unstable coronary disease Congestive heart failure refractory to medical management Malignancy with bone instability Inmates

Ages Eligible for Study
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Minimum Age: 18 Years

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

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (early intervention)<br>Beginning within 2 weeks of starting chemoradiation, patients undergo an individualized rehabilitation program comprising aerobic exercise and strength training, including treadmill walking, stationary bicycle, NU-Step, upper body resistance training and breathing retraining, 3 times per week for 8 weeks (36 sessions). | Behavioral: exercise intervention<br>* Undergo pulmonary rehabilitation<br>Procedure: pulmonary complications management/prevention<br>* Undergo pulmonary rehabilitation<br>Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;Other: questionnaire administration<br>* Ancillary studies<br>|
| Experimental: Arm II (late intervention)<br>Beginning 1 month after completion of chemoradiation, patients undergo an individualized exercise rehabilitation program as in Arm I. | Behavioral: exercise intervention<br>* Undergo pulmonary rehabilitation<br>Procedure: pulmonary complications management/prevention<br>* Undergo pulmonary rehabilitation<br>Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;Other: questionnaire administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent improvement in the 6 minute walk from prior to post PR | Either a two-sided t-test or a Wilcoxon-rank sum test will be used to test the difference in the improvement of the 6 minute walk depending on the distribution. This test will be used to compare the difference in improvement between PR during chemo-radiation of NSCLC patients and PR 8 weeks post chemo-radiation. Linear regression will be used to estimate which clinical characteristics and patient demographics are associated with improvement in 6 minute walk. The study population will be described using means and standard deviations or medians and the interquartile range. | Baseline to up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent improvement in the St. George Respiratory Questionnaire (SGRQ) score |  | Baseline to up to 8 weeks | 
| Feasibility of the program, based on number of patients attending the sessions throughout the 8 weeks | Either Pearson's chi-square of Fisher's exact methods will be used to test if the feasibility differs across groups. Logistic regression will be used to estimate which clinical characteristics and patient demographics are associated with feasibility. | Up to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Rehabilitation, Non-Small Cell Lung Cancer, NSCLC