The Improvement of the Quality of Life and Exercise Capacity Through Pulmonary Rehabilitation in Lung Cancer Patients Receiving Radiation Therapy
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change of 6 minutes walking test at 7 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Change of 6 minutes walking test at 7 months
时间窗: 7 months
Change of walking distance from baseline 6 minutes walking test at 7 months
次要结局
- Forced Vital Capacity at 7 months(7 months)
- Forced Expiratory Volume in 1 sec at 1 month(1 month)
- Carbon monoxide diffusing capacity at 1 month(1 month)
- Forced Expiratory Volume in 1 sec at 7 months(7 months)
- Forced Vital Capacity at 1 month(1 month)
- Carbon monoxide diffusing capacity at 7 months(7 months)
- Change of dyspnea scale at 1 month(1 month)
- Maximal inspiratory pressure at 7 months(7 months)
- Maximal expiratory pressure at 1 month(1 month)
- Radiation therapy related pneumonitis(From the initiation of radiation therapy to 7 months at end of radiation therapy)
- Skeletal muscle mass at 1 month(1 month)
- Appendicular muscle mass at 1 month(1 month)
- Change of The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 at 7 months(7 months)
- All cause mortality(From the initiation of radiation therapy to 7 months at end of radiation therapy)
- Maximal expiratory pressure at 7 months(7 months)
- Appendicular muscle mass at 7 months(7 months)
- Change of The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 at 7 months(7 months)
- Change of The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 at 1 month(1 month)
- Change of dyspnea scale at 7 months(7 months)
- Skeletal muscle mass at 7 months(7 months)
- Change of 6 minutes walking test at 1 month(1 month)
- Grip strength at 7 months(7 months)
- Grip strength at 1 month(1 month)
- Maximal inspiratory pressure at 1 month(1 month)
- Change of The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 at 1 month(1 month)
研究者
Sei Won Lee
Assistant Professor
Asan Medical Center