Beneficial Effect of Pulmonary Rehabilitation in Lung Cancer Patients Receiving Radiation Therapy

Study Overview
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Brief Summary
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It is important for clinicians to maintain and support for exercise capacity and quality of life of lung cancer patients after radiation therapy, because radiation therapy also affect the lung function and general conditions of patients. The effect and safety of pulmonary rehabilitation is well-proven in various diseases. Because there is no standard treatment, the investigators will perform this study to clearly prove the effect of pulmonary rehabilitation in lung cancer patients receiving radiation therapy.

Detailed Description
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Roles of the radiation therapy in lung cancer are as followings; 1) to treat the lung caner stage 1  2 patients, who are inadequate for operation due to declined lung function, 2) to treat the locally advanced and inoperable stage 3 patients with concurrent chemotherapy, and 3) to palliatively treat the stage 4 patient. However, it is also possible that radiation therapy worsens the general weakness and lung function, although the degree of deterioration was generally less than lung resection. Therefore, it is crucial for clinicians to maintain and support for exercise capacity and quality of life of lung cancer patients after radiation therapy. The effect and safety of pulmonary rehabilitation is well-proven in various diseases. Investigators presented a retrospective study about the effect of pulmonary rehabilitation in patients receiving radiation therapy, which showed less decreased lung function, less radiation related pneumonitis, and decreased mortality. Investigators will perform this study to clearly prove the effect of pulmonary rehabilitation in lung cancer patients receiving radiation therapy.

Official Title
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The Improvement of the Quality of Life and Exercise Capacity Through Pulmonary Rehabilitation in Lung Cancer Patients Receiving Radiation Therapy

Conditions
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Lung Neoplasm Malignant

Intervention / Treatment
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* Behavioral: Pulmonary rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lung cancer patients with scheduled radiation therapy (postoperative adjuvant radiation therapy and concurrent chemoradiation therapy) during more than 4 weeks (5 times a week, 20 times a week) Lung parenchymal cancer Consent to regular outpatient-based pulmonary rehabilitation program, considering residence and other factors. Exclusion Criteria: Communication restrictions Failed to obtain consent form Accompanied by psychiatric problems or severe dizziness Patients have comorbidities, which are regarded as contraindications of pulmonary rehabilitation, such as severe pulmonary hypertension or hemodynamic instability

Ages Eligible for Study
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Minimum Age: 20 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pulmonary rehabilitation group<br>Patients will receive the radiation therapy according to the existing schedule. Additionally, patients in pulmonary rehabilitation group will participate pulmonary rehabilitation program more than two times per week. | Behavioral: Pulmonary rehabilitation<br>* Pulmonary rehabilitation runs for 60 minutes per session. The pulmonary rehabilitation program is based on a comprehensive approach, not simply providing regular exercise. And it includes patient education, active encouragement, and psychological support by investigators. Exercise is performed more than twice a week. Each session is performed for 60 minutes and includes breathing exercises, low to medium-intensity aerobic exercises, and muscle exercises under the guidance of a investigator. After radiation therapy is completed, investigators will recommend that patients perform pulmonary rehabilitation at home more than twice a week and for 60 minutes or more. The patients will record whether and when exercise is performed every day in the diary for pulmonary rehabilitation.<br>|
| No Intervention: Control group<br>Patients will receive the radiation therapy according to the existing schedule. There will be no additional treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of 6 minutes walking test at 7 months | Change of walking distance from baseline 6 minutes walking test at 7 months | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality | All cause mortality during study periods | From the initiation of radiation therapy to 7 months at end of radiation therapy | 
| Radiation therapy related pneumonitis | Radiation therapy related pneumonitis requiring steroid therapy | From the initiation of radiation therapy to 7 months at end of radiation therapy | 
| Forced Expiratory Volume in 1 sec at 7 months | Forced Expiratory Volume in 1 sec (L, predicted percentage) at 7 months | 7 months | 
| Forced Expiratory Volume in 1 sec at 1 month | Forced Expiratory Volume in 1 sec (L, predicted percentage) at 1 month | 1 month | 
| Forced Vital Capacity at 7 months | Forced Vital Capacity (L, predicted percentage) at 7 months | 7 months | 
| Forced Vital Capacity at 1 month | Forced Vital Capacity (L, predicted percentage) at 1 month | 1 month | 
| Carbon monoxide diffusing capacity at 7 months | Carbon monoxide diffusing capacity (mL/mmHg/min, predicted percentage) at 7 months | 7 months | 
| Carbon monoxide diffusing capacity at 1 month | Carbon monoxide diffusing capacity (mL/mmHg/min, predicted percentage) at 1 month | 1 month | 
| Change of dyspnea scale at 7 months | Investigators will measure the change from the baseline Modified Medical Research Council Dyspnea Scale in the range of 0 to 4, which means the higher the result, the more severe the degree of dyspnea | 7 months | 
| Change of dyspnea scale at 1 month | Investigators will measure the change from the baseline Modified Medical Research Council Dyspnea Scale in the range of 0 to 4, which means the higher the result, the more severe the degree of dyspnea | 1 month | 
| Grip strength at 7 months | Grip strength will be measured by digital group hand dynamometer | 7 months | 
| Grip strength at 1 month | Grip strength will be measured by digital group hand dynamometer | 1 month | 
| Maximal inspiratory pressure at 7 months | To evaluated respiratory muscle strength, investigators will measure maximal inspiratory pressure by portable spirometry | 7 months | 
| Maximal expiratory pressure at 7 months | To evaluated respiratory muscle strength, investigators will measure maximal expiratory pressure by portable spirometry | 7 months | 
| Maximal inspiratory pressure at 1 month | To evaluated respiratory muscle strength, investigators will measure maximal inspiratory pressure by portable spirometry | 1 month | 
| Maximal expiratory pressure at 1 month | To evaluated respiratory muscle strength, investigators will measure maximal expiratory pressure by portable spirometry | 1 month | 
| Skeletal muscle mass at 7 months | Investigators will measure the skeletal muscle mass by bioimpedance | 7 months | 
| Skeletal muscle mass at 1 month | Investigators will measure the skeletal muscle mass by bioimpedance | 1 month | 
| Appendicular muscle mass at 1 month | Investigators will measure the appendicular muscle mass by bioimpedance | 1 month | 
| Appendicular muscle mass at 7 months | Investigators will measure the appendicular muscle mass by bioimpedance | 7 months | 
| Change of The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 at 7 months | Investigators will assess change from the baseline quality of life of patients by questionnaire (The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13) at 7 months. (the higher values indicate a greater degree of symptoms, min.: 0, max.: 100) | 7 months | 
| Change of The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 at 7 months | Investigators will assess change from the baseline quality of life of patients by questionnaire (The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30) at 7 months. (the higher values indicate a greater degree of symptoms, min.: 0, max.: 100) | 7 months | 
| Change of The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 at 1 month | Investigators will assess change from the baseline quality of life of patients by questionnaire (The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13) at 1 month. (the higher values indicate a greater degree of symptoms, min.: 0, max.: 100) | 1 month | 
| Change of The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 at 1 month | Investigators will assess change from the baseline quality of life of patients by questionnaire (The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30) at 1 month. (the higher values indicate a greater degree of symptoms, min.: 0, max.: 100) | 1 month | 
| Change of 6 minutes walking test at 1 month | Change of walking distance from baseline 6 minutes walking test at 1 month | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary rehabilitation, Radiation therapy, Lung cancer