Phase III Trial of Exercise Training in Postsurgical Lung Cancer

描述(申请人提供)：肺癌是美国男性和女性癌症相关死亡的最常见原因。早期肺癌患者由于多种机制(如疾病病理生理、治疗、解除条件等)导致运动能力显著降低。这一点至关重要，因为运动能力差与更高的疾病相关症状、较差的健康相关生活质量(HRQOL)、对常见年龄相关疾病的易感性增加以及可能的过早死亡相关。尽管它很重要，但目前还没有有效的干预措施来提高肺癌患者的运动能力。来自我们小组的两项非对照先导研究的结果为有氧训练是一种安全可行的干预措施提供了“原则证据”，与运动能力和早期肺癌患者的HRQOL的适度改善有关。以下两个问题现在是密切相关的：(1)什么类型的运动训练最有效地提高运动能力；(2)这种改善背后的机制是什么？我们提出了一项前瞻性、四臂、随机试验，在150名完成癌症治疗的早期肺癌患者中，比较三种不同运动方案相对于久坐对照组的效果。这笔赠款将有以下主要和次要目标：主要目标：确定有氧训练和阻力训练相对于注意力控制对运动能力的影响。次要目标：(1)确定对患者报告结果的影响，(2)检查运动训练-VO2峰值关系的生理中介，(3)检查干预-患者-报告结果关系的心理中介。这项研究将解决几个基本但目前尚未回答的问题，即运动训练在肺癌管理中的作用。从这项临床试验中获得的信息将在未来计划的研究中为设计提供依据，进一步调查运动训练在肺癌存活期中的作用。最后，这些机械性的发现将为如何改进运动训练干预措施，以最大限度地提高这一服务不足的人群的运动能力和相关结果提供洞察。公共卫生相关性：肺癌是美国男性和女性癌症相关死亡的最常见原因。早期肺癌患者由于多种机制(如疾病病理生理、治疗、解除条件等)导致运动能力显著降低。这一点至关重要，因为运动能力差与更高的疾病相关症状、较差的健康相关生活质量(HRQOL)、对常见年龄相关疾病的易感性增加以及可能的过早死亡相关。尽管它很重要，但目前还没有有效的干预措施来提高肺癌患者的运动能力。

DESCRIPTION (provided by applicant): Lung cancer is the most common cause of cancer-related death among both men and women in the United States. Individuals with early-stage lung cancer have markedly reduced exercise capacity caused by multiple mechanisms (e.g., disease pathophysiology, treatment, deconditioning, etc.). This is of critical importance since poor exercise capacity is associated with higher disease-related symptoms, poor health-related quality of life (HRQOL), increased susceptibility to common age-related diseases and likely, premature death. Despite its importance, effective interventions to improve exercise capacity among lung cancer patients are not available. Results from two uncontrolled pilot studies from our group have provided 'proof of principle' that aerobic training is a safe and feasible intervention associated with modest improvements in exercise capacity and HRQOL among early-stage lung cancer patients. The following two questions are now germane: (1) what is the most effective type of exercise training to improve exercise capacity; and (2) what are the mechanisms underlying this improvement? We propose a prospective, four-arm, randomized trial to compare the effects of three different exercise programs relative to a sedentary control group among 150 early-stage lung cancer patients who have completed cancer therapy. This grant will have the following primary and secondary aims: Primary aim: determine the effects of aerobic training and resistance training, relative to attention-control, on exercise capacity. Secondary aims: (1) to determine the effects on patient-reported outcomes, (2) to examine the physiological mediators of the exercise training - VO2peak relationship, (3) to examine the psychological mediators of the intervention - patient-reported outcomes relationship. This study will address several fundamental but, currently unanswered questions regarding the role of exercise training in the management of lung cancer. Information gained from this clinical trial will inform the design in future-planned studies further investigating the role of exercise training across the lung cancer survivorship continuum. Finally, the mechanistic findings will provide insight into how to refine exercise training interventions to maximize improvements in exercise capacity and associated outcomes in this underserved population. PUBLIC HEALTH RELEVANCE: Lung cancer is the most common cause of cancer-related death among both men and women in the United States. Individuals with early-stage lung cancer have markedly reduced exercise capacity caused by multiple mechanisms (e.g., disease pathophysiology, treatment, deconditioning, etc.). This is of critical importance since poor exercise capacity is associated with higher disease-related symptoms, poor health-related quality of life (HRQOL), increased susceptibility to common age-related diseases and likely, premature death. Despite its importance, effective interventions to improve exercise capacity among lung cancer patients are not available.