Feasibility of an Exercise and Dietary Intervention in Men on Prolonged ADT

描述（由申请人提供）：雄激素剥夺疗法是转移性前列腺癌（PC）治疗的基础，现在经常被纳入局部晚期前列腺癌的多模式治疗策略中。不幸的是，ADT的分解代谢效应会导致显著的发病率，包括瘦肌肉量的减少、脂肪量的增加、肌肉力量的减少和骨密度的降低。反过来，ADT的这些不良影响与功能下降和虚弱有关。新出现的证据还表明，服用ADT的男性患心血管疾病和代谢综合征的风险更大。因此，越来越清楚的是，PC患者的身体功能、健康状况和生活质量（QOL）受到长期和挥之不去的影响，这是ADT作为更有效的癌症控制和延长寿命的“权衡”。有人提出，生活方式的改变，包括运动和饮食行为的改变，可能抵消甚至逆转长期服用ADT的不良影响。随着临床对改善癌症生存质量的关注日益增加，迫切需要确定生活方式干预措施，以有效抵消ADT的不良影响，并最大限度地降低正在接受治疗的PC患者的功能下降和慢性疾病的风险。我们的长期研究目标是开发创新和有效的生活方式干预措施，用于治疗长期ADT的PC患者。然而，基于理论的个性化运动和饮食干预对改善长期ADT男性的功能限制、慢性疾病危险因素和生活质量的有效性的经验证据是有限的。此外，生活方式、运动和饮食干预对这些临床相关结果产生改善的途径尚未确定。我们的中心假设是：1)理论驱动的、个性化的运动和饮食干预将在功能限制、身体组成和生活质量方面产生优于标准护理治疗方法的改善；2)功能限制和生活质量的干预效果将通过改善自我效能感信念和中间失能过程模型结果间接起作用。当前应用的目的是确定运动和饮食干预对接受ADT的PC患者的功能、疾病和生活质量结果的可行性和初步疗效。在这项研究完成后，我们的研究结果的主要积极影响将是基于证据的科学验证生活方式，运动和饮食干预在预防和治疗PC患者长期ADT的不良反应方面的有效性。这项拟议的调查有可能迅速影响医学界及其对ADT的方法。如果运动和饮食调整的个性化方法能改善结果，我们将有必要的证据改变目前男性ADT的临床实践。

DESCRIPTION (provided by applicant): Androgen-deprivation therapy is the foundation of treatment for men with metastatic prostate cancer (PC) and is now frequently incorporated into multimodality strategies for the curative treatment of locally advanced PC. Unfortunately, the catabolic effects of ADT result in significant morbidity including loss of lean muscle mass, increased fat mass, reduced muscle strength, and lower bone mineral density. In turn, these adverse effects of ADT are linked with functional decline and frailty. Emerging evidence also suggests that men on ADT are at greater risk for cardiovascular disease and the onset of metabolic syndrome. Thus, it is becoming increasingly clear that PC patients endure long and lingering impacts on physical function, health status, and quality of life (QOL) that accompany ADT as a "trade-off" for more effective cancer control and extended longevity. It has been proposed that lifestyle modification, including change in exercise and dietary behaviors, may offset, or even reverse, the adverse effects that accompany long-term administration of ADT. With a growing clinical focus upon improvements in QOL in cancer survivorship, there is a critical need to identify lifestyle interventions that are effective in offsetting the adverse effets of ADT and minimizing the risk of functional decline and chronic disease in PC patients undergoing treatment. Our long term research goal is to develop innovative and effective lifestyle interventions for the treatment of PC patients undergoing prolonged ADT. However, empirical evidence documenting the efficacy of theory-based, personalized exercise and dietary interventions for improving functional limitations, chronic disease risk factors, and QOL in men on prolonged ADT is limited. Additionally, the pathways through which lifestyle, exercise, and dietary interventions produce improvements in these clinically relevant outcomes have yet to be defined. Our central hypotheses are that: 1) a theory-driven, personalized exercise and dietary intervention will produce superior improvements in functional limitations, body composition, and quality of life relative to a standard of care treatment approach and 2) the intervention effects o functional limitations and QOL will be indirect operating through improvements in self-efficacy beliefs and intermediate disablement process model outcomes. The objective for this current application is to determine the feasibility and preliminary efficacy of an exercise and dietary intervention upon functional, disease, and QOL outcomes in PC patients undergoing ADT. Upon completion of this investigation, the primary positive impact of our findings would be evidence-based scientific verification of the efficacy of lifestyle, exercise, and dietary interventions in prevention and treatment of the adverse effects of prolonged ADT in PC patients. This proposed investigation has the potential to rapidly impact the medical community and their approach to ADT. Should the personalized approach to exercise and dietary modification improve outcomes, we will have the evidence necessary to alter current clinical practice of men on ADT.