群体介导的运动和饮食干预对接受雄激素剥夺治疗的前列腺癌患者的影响：来自 IDEA-P 试验的结果。
Effects of a Group-Mediated Exercise and Dietary Intervention in the Treatment of Prostate Cancer Patients Undergoing Androgen Deprivation Therapy: Results From the IDEA-P Trial.
机构信息
Exercise and Behavioral Medicine Laboratory, Kinesiology, The Ohio State University, Columbus, OH, USA.
Comprehensive Cancer Center, The Ohio State University, Columbus, OH, USA.
出版信息
Ann Behav Med. 2018 Apr 19;52(5):412-428. doi: 10.1093/abm/kax002.
BACKGROUND
Although androgen-deprivation therapy (ADT) is the foundation of treatment for prostate cancer, the physiological impacts of ADT result in functional decline and enhanced risk of chronic disease and metabolic syndrome.
PURPOSE
The Individualized Diet and Exercise Adherence Pilot Trial (IDEA-P) is a single-blind, randomized, pilot trial comparing the effects of a group-mediated, cognitive-behavioral (GMCB) exercise and dietary intervention (EX+D) with those of a standard-of-care (SC) control during the treatment of prostate cancer patients undergoing ADT.
METHODS
A total of 32 prostate cancer patients (M age = 66.28, SD = 7.79) undergoing ADT were randomly assigned to the 12-week EX+D intervention (n = 16) or control (n = 16). The primary outcome in IDEA-P was change in mobility performance with secondary outcomes including body composition and muscular strength. Blinded assessment of outcomes were obtained at baseline and at 2- and 3-month follow-ups.
RESULTS
Favorable adherence and retention rates were observed, and no serious intervention-related adverse events were documented. Intent-to-treat ANCOVA controlling for baseline value and ADT duration demonstrated that EX+D resulted in significantly greater improvements in mobility performance (p < .02), muscular strength (p < .01), body fat percentage (p < .05), and fat mass (p < .03) at 3-month follow-up, relative to control.
CONCLUSION
Findings from the IDEA-P trial suggest that a GMCB-based EX+D intervention resulted in significant, clinically meaningful improvements in mobility performance, muscular strength, and body composition, relative to controls. Collectively, these results suggest that the EX+D was a safe and well-tolerated intervention for prostate cancer patients on ADT. The utility of implementing this approach in the treatment of prostate cancer patients on ADT should be evaluated in future large-scale efficacy trials.
CLINICAL TRIAL INFORMATION
NCT02050906.
背景
尽管雄激素剥夺疗法（ADT）是前列腺癌治疗的基础，但 ADT 的生理影响导致功能下降，并增加了慢性疾病和代谢综合征的风险。
目的
个体化饮食和运动依从性试验（IDEA-P）是一项单盲、随机、试验性试验，比较了群体介导的认知行为（GMCB）运动和饮食干预（EX+D）与标准护理（SC）对照在接受 ADT 的前列腺癌患者治疗中的效果。
方法
共有 32 名接受 ADT 的前列腺癌患者（M 年龄=66.28，SD=7.79）被随机分配到 12 周的 EX+D 干预组（n=16）或对照组（n=16）。IDEA-P 的主要结果是移动性能的变化，次要结果包括身体成分和肌肉力量。在基线和 2 个月和 3 个月的随访时进行盲法评估结果。
结果
观察到良好的依从性和保留率，并且没有记录到与干预相关的严重不良事件。意向治疗 ANCOVA 控制基线值和 ADT 持续时间表明，EX+D 导致移动性能（p<0.02）、肌肉力量（p<0.01）、体脂肪百分比（p<0.05）和脂肪质量（p<0.03）在 3 个月的随访时，与对照组相比有显著改善。
结论
IDEA-P 试验的结果表明，基于 GMCB 的 EX+D 干预与对照组相比，显著改善了移动性能、肌肉力量和身体成分，具有临床意义。总的来说，这些结果表明，EX+D 是一种安全且耐受良好的 ADT 前列腺癌患者的干预措施。在未来的大规模疗效试验中，应评估在 ADT 前列腺癌患者中实施这种方法的效用。
临床试验信息
NCT02050906。
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