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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary rehabilitation group | Active Comparator | 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. |
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| Control group | No Intervention | Patients will receive the radiation therapy according to the existing schedule. There will be no additional treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary rehabilitation | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sei Won Lee, MD, PhD | Contact | +82-2-3010-3990 | 3990 | iseiwon@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jang Ho Lee, MD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center, University of Ulsan College of Medicine | Seoul | Songpa | 05505 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40306134 | Derived | Lee JH, Cha S, Ko EJ, Kim W, Kim SS, Song SY, Jeon JY, Ji W, Choi CM, Lee SH, Lee SW. Clinical effect of pulmonary rehabilitation during radiotherapy in lung cancer: A randomized controlled trial. Lung Cancer. 2025 Jun;204:108546. doi: 10.1016/j.lungcan.2025.108546. Epub 2025 Apr 17. |
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The datasets used and/or analysed during the current study will be available from the primary investigator on reasonable request after end of the study.
Investigators anticipate our study will be finished until December 31, 2023. After end of the study, investigators might consider to share the individual participant data.
The datasets used and/or analysed during the current study will be available from the primary investigator on reasonable request after end of the study.
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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 |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |