Effect of a Pulmonary Rehabilitation Program on Skeletal Muscle Mass, Pulmonary Function, Inflammatory Response and Overall Survival on Patients Diagnosed With Non-small-cell Advanced Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Pulmonary function
研究概览
简要总结
Lung cancer (LC) is usually diagnosed in advanced stages and continues to be the leading cause of cancer related deaths worldwide. Cancer cachexia are frequent among patients with LC affecting up to 80% of patients with advanced stage disease, and it has been related with higher risk of complications, length of hospital stay, and worst overall survival. During cancer cachexia, both muscle and fat mass can be wasted, however, the loss of muscle mass has been associated to higher treatment related toxicity, loss of functional status, shorter progression free survival and overall survival in different types of cancer under various treatments. Hence, preservation of muscle mass and function should be an important focus of the multidisciplinary treatment of patients with LC.
Pulmonary rehabilitation (PR) has been known to improve pulmonary function, reduce fatigue and improve exercise tolerance in patients with LC undergoing curative surgery. However, few studies have focused on the efficacy of PR on patients with advanced cancer undergoing palliative care with chemotherapy or targeted therapies.
详细描述
The main objective of this study is to determine the effects of a pulmonary rehabilitation program on the pulmonary function and muscle mass. Moreover, the effects on exercise tolerance, inflammatory response, quality of live and overall survival will be explored.
Patients will be randomized into intervention group (IG) or control group (CG). Patients in the IG will be scheduled to receive 12 sessions of PR over a period of 4-6 weeks (2-3 session/week). CG will receive information and recommendations on physical activity. Both groups will receive nutritional assessment and intervention as needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of advanced non-small-cell lung cancer
- •Good performance status (ECOG 0-1)
- •Life expectancy >12 weeks
- •Eligible to receive treatment with chemotherapy or tyrosinkinase inhibitors
- •Recent electrocardiogram without evidence of arrythmia
排除标准
- •Symptomatic brain metastasis
- •Uncontrolled pain (Visual Analog Scale >5)
- •Uncontrolled hypertension (>140/100mmHg)
- •Practice of regular moderate to intense physical activity at least 3 day/week
- •Not residents of Mexico City or unable to attend to therapy sessions
研究组 & 干预措施
Intervention Group
Patients in the IG will be scheduled to receive Pulmonary Rehabilitation:
12 sessions (60 minutes approximately) over a period of 4-6 weeks (2-3 session/week). Sessions will progress as patients tolerance to exercise and will include breathing techniques, resistance training on ergometer and treadmill.
干预措施: Pulmonary rehabilitation (Other)
Control Group
CG will receive information and recommendations on physical activity
结局指标
主要结局
Pulmonary function
时间窗: After 12 sessions (6 weeks)
Pulmonary function Maximal expiratory and inspiratory pressure units: cm H2O (measured with Jaeger spirometer)
次要结局
- Muscle mass(After 12 sessions (6 weeks))
- Anxiety and Depression(After 12 sessions (6 weeks))
- Inflammatory response(After 12 sessions (6 weeks))
- Exercise tolerance(After 12 sessions (6 weeks))
- Quality of Life in lung cancer(the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire is applied before and after a follow-up after 12 sessions (6 weeks).)
- Lung Cancer Quality of Life(After 12 sessions (6 weeks))
研究者
Oscar Gerardo Arrieta Rodríguez
Principal Investigator, Head of the Thoracic Oncology Unit
Instituto Nacional de Cancerologia de Mexico