PDF(Pubmed)
Abstract：
BACKGROUND: Muscle mass is important for metastatic prostate cancer survival and quality of life (QoL). The backbone of treatment for men with metastatic castration sensitive prostate cancer (mCSPC) is androgen deprivation therapy (ADT) with an androgen signaling inhibitor. ADT is an effective cancer treatment, but it facilitates significant declines in muscle mass and adverse health outcomes important to mCSPC survivors, such as fatigue, and reductions in physical function, independence, insulin sensitivity, and QoL. In non-metastatic CSPC survivors, resistance training (RT) preserves muscle mass and improves these related health outcomes, but the biggest barrier to RT in CSPC survivors of all stages is fatigue. Creatine monohydrate supplementation coupled with RT (Cr + RT) may address this barrier since creatine plays a critical role in energy metabolism. Cr + RT in cancer-free older adults and other clinical populations improves muscle mass and related health outcomes. Evidence also suggests that creatine supplementation can complement cancer treatment. Thus, Cr + RT is a strategy that addresses gaps in survivorship needs of people with mCSPC. The purpose of this parallel, double-blind randomized controlled trial is to test the effects of 52-weeks of Cr + RT compared with placebo (PLA) and RT (PLA + RT) on muscle mass, other related health outcomes, and markers of cancer progression.
METHODS: We will carry out this trial with our team\'s established, effective, home-based, telehealth RT program in 200 mCSPC survivors receiving ADT, and evaluate outcomes at baseline, 24-, and 52-weeks. RT will occur twice weekly with elastic resistance bands, and an established creatine supplementation protocol will be used for supplementation delivery. Our approach addresses a major facilitator to RT in mCSPC survivors, a home-based RT program, while utilizing a supervised model for safety.
CONCLUSIONS: Findings will improve delivery of comprehensive survivorship care by providing a multicomponent, patient-centered lifestyle strategy to preserve muscle mass, improve health outcomes, and complement cancer treatment (NCT06112990).
METHODS: We will carry out this trial with our team\'s established, effective, home-based, telehealth RT program in 200 mCSPC survivors receiving ADT, and evaluate outcomes at baseline, 24-, and 52-weeks. RT will occur twice weekly with elastic resistance bands, and an established creatine supplementation protocol will be used for supplementation delivery. Our approach addresses a major facilitator to RT in mCSPC survivors, a home-based RT program, while utilizing a supervised model for safety.
CONCLUSIONS: Findings will improve delivery of comprehensive survivorship care by providing a multicomponent, patient-centered lifestyle strategy to preserve muscle mass, improve health outcomes, and complement cancer treatment (NCT06112990).
摘要：
背景：肌肉质量对于转移性前列腺癌的生存和生活质量（QoL）很重要。转移性去势敏感性前列腺癌（mCSPC）男性的主要治疗方法是使用雄激素信号传导抑制剂的雄激素剥夺疗法（ADT）。ADT是一种有效的癌症治疗方法，但它促进了肌肉质量的显著下降和对mCSPC幸存者重要的不良健康结果，比如疲劳，和身体机能的下降，独立性,胰岛素敏感性，和QoL。在非转移性CSPC幸存者中，阻力训练（RT）保持肌肉质量并改善这些相关的健康结果，但在CSPC所有阶段的幸存者中，RT的最大障碍是疲劳。补充肌酸一水合物与RT(Cr+RT)结合可以解决该障碍,因为肌酸在能量代谢中起关键作用。无癌老年人和其他临床人群的Cr+RT改善了肌肉质量和相关的健康结果。证据还表明，补充肌酸可以补充癌症治疗。因此，CrRT是一种解决mCSPC患者生存需求差距的策略。这种平行的目的，双盲随机对照试验是为了测试52周Cr+RT与安慰剂（PLA）和RT（PLA+RT）对肌肉质量的影响，其他相关的健康结果，和癌症进展的标志物。
方法：我们将在我们成立的团队中进行这项试验，有效,以家庭为基础，200名接受ADT的mCSPC幸存者的远程健康RT计划，并评估基线结果，24-,52周。RT将每周发生两次，并带有弹性阻力带，建立的肌酸补充方案将用于补充递送。我们的方法解决了mCSPC幸存者中RT的主要促进者，基于家庭的RT程序，同时利用安全监督模型。
结论：研究结果将通过提供多组分来改善综合生存护理的提供，以患者为中心的生活方式策略，以保持肌肉质量，改善健康结果，和补体癌症治疗（NCT06112990）。
方法：我们将在我们成立的团队中进行这项试验，有效,以家庭为基础，200名接受ADT的mCSPC幸存者的远程健康RT计划，并评估基线结果，24-,52周。RT将每周发生两次，并带有弹性阻力带，建立的肌酸补充方案将用于补充递送。我们的方法解决了mCSPC幸存者中RT的主要促进者，基于家庭的RT程序，同时利用安全监督模型。
结论：研究结果将通过提供多组分来改善综合生存护理的提供，以患者为中心的生活方式策略，以保持肌肉质量，改善健康结果，和补体癌症治疗（NCT06112990）。
