Lung Neoplasm Malignant
Conditions
Keywords
Pulmonary rehabilitation, Radiation therapy, Lung cancer
Brief summary
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
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.
Interventions
BEHAVIORALPulmonary rehabilitation
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.
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of 6 minutes walking test at 7 months | 7 months | Change of walking distance from baseline 6 minutes walking test at 7 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiation therapy related pneumonitis | From the initiation of radiation therapy to 7 months at end of radiation therapy | Radiation therapy related pneumonitis requiring steroid therapy |
| Forced Expiratory Volume in 1 sec at 7 months | 7 months | Forced Expiratory Volume in 1 sec (L, predicted percentage) at 7 months |
| Forced Expiratory Volume in 1 sec at 1 month | 1 month | Forced Expiratory Volume in 1 sec (L, predicted percentage) at 1 month |
| Forced Vital Capacity at 7 months | 7 months | Forced Vital Capacity (L, predicted percentage) at 7 months |
| Forced Vital Capacity at 1 month | 1 month | Forced Vital Capacity (L, predicted percentage) at 1 month |
| Carbon monoxide diffusing capacity at 7 months | 7 months | Carbon monoxide diffusing capacity (mL/mmHg/min, predicted percentage) at 7 months |
| Carbon monoxide diffusing capacity at 1 month | 1 month | Carbon monoxide diffusing capacity (mL/mmHg/min, predicted percentage) at 1 month |
| Change of dyspnea scale at 7 months | 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 |
| Change of dyspnea scale at 1 month | 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 |
| Grip strength at 7 months | 7 months | Grip strength will be measured by digital group hand dynamometer |
| Grip strength at 1 month | 1 month | Grip strength will be measured by digital group hand dynamometer |
| Maximal inspiratory pressure at 7 months | 7 months | To evaluated respiratory muscle strength, investigators will measure maximal inspiratory pressure by portable spirometry |
| All cause mortality | From the initiation of radiation therapy to 7 months at end of radiation therapy | All cause mortality during study periods |
| Maximal inspiratory pressure at 1 month | 1 month | To evaluated respiratory muscle strength, investigators will measure maximal inspiratory pressure by portable spirometry |
| Maximal expiratory pressure at 1 month | 1 month | To evaluated respiratory muscle strength, investigators will measure maximal expiratory pressure by portable spirometry |
| Skeletal muscle mass at 7 months | 7 months | Investigators will measure the skeletal muscle mass by bioimpedance |
| Skeletal muscle mass at 1 month | 1 month | Investigators will measure the skeletal muscle mass by bioimpedance |
| Appendicular muscle mass at 1 month | 1 month | Investigators will measure the appendicular muscle mass by bioimpedance |
| Appendicular muscle mass at 7 months | 7 months | Investigators will measure the appendicular muscle mass by bioimpedance |
| Change of The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 at 7 months | 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) |
| Change of The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 at 7 months | 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) |
| Change of The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 at 1 month | 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) |
| Change of The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 at 1 month | 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) |
| Change of 6 minutes walking test at 1 month | 1 month | Change of walking distance from baseline 6 minutes walking test at 1 month |
| Maximal expiratory pressure at 7 months | 7 months | To evaluated respiratory muscle strength, investigators will measure maximal expiratory pressure by portable spirometry |
Countries
South Korea
Contacts
Primary ContactSei Won Lee, MD, PhD
Outcome results
None listed