Protocol for a 4-arm randomized controlled trial testing remotely delivered exercise-only, diet-only, and exercise + diet interventions among men with prostate cancer treated with radical prostatectomy (Prostate 8-II).
Protocol for a 4-arm randomized controlled trial testing remotely delivered exercise-only, diet-only, and exercise + diet interventions among men with prostate cancer treated with radical prostatectomy (Prostate 8-II).
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一项 4 臂随机对照试验方案，测试远程对接受根治性前列腺切除术 (Prostate 8-II) 治疗的前列腺癌男性进行仅运动、仅饮食和运动饮食干预。
DOI：
10.1016/j.cct.2023.107079
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发表时间：
2023
影响因子：
2.2
通讯作者：
Kenfield,StaceyA
中科院分区：
文献类型：
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作者：
VanBlarigan,ErinL;Chan,JuneM;Sanchez,Ada;Zhang,Li;Winters-Stone,Kerri;Liu,Vivian;Macaire,Greta;Panchal,Neil;Graff,RebeccaE;Tenggara,Imelda;Luke,Anthony;Simko,JeffryP;Cooperberg,MatthewR;Carroll,PeterR;Kenfield,StaceyA
背景营养和体力活动与前列腺癌复发和死亡率相关。很少有随机对照试验 (RCT) 检验长期运动和饮食变化对前列腺癌临床、生物学和患者报告结果的影响。方法前列腺 8-II 是一项 4 组随机对照试验，受试者为 200 名选择根治性前列腺切除术 (RP) 作为主要治疗的前列腺癌男性。男性在 RP 之前入组，并随机分为仅运动组、仅饮食组、运动+饮食组或常规护理组（50 人/组）。参与者在 RP 前 0-5 周开始指定的干预，并在手术后持续 24 个月。 3 个主动干预组可以访问门户网站、短信、辅导电话和其他干预资源（例如心率传感器和阻力带和/或食谱手册）。运动干预组的每周运动目标是 150 分钟中等强度或 75 分钟剧烈有氧运动、2 次力量训练和 2 次灵活性训练。饮食干预小组与营养师合作制定他们的目标（例如，增加十字花科蔬菜、煮熟的西红柿、健康脂肪、鱼类；限制加工肉类、全脂牛奶）。主要终点是生化复发。次要终点包括肿瘤生物标志物从活检到 RP 的变化，以及患者报告的结果（例如生活质量）、血液和尿液生物标志物以及 0、6、12 和 24 个月时的人体测量。结论这项 4 臂随机对照试验将检查运动和饮食变化（单独或组合）对前列腺癌复发、生物学和生活质量的影响。
BackgroundNutrition and physical activity are associated with prostate cancer recurrence and mortality. Few randomized controlled trials (RCT) have examined the effects of long-term exercise and diet changes on prostate cancer clinical, biological, and patient-reported outcomes.MethodsProstate 8-II is a 4-arm RCT among 200 men with prostate cancer who chose radical prostatectomy (RP) as their primary treatment. Men are enrolled prior to RP and randomized to exercise-only, diet-only, exercise + diet, or usual care (50/arm). Participants begin their assigned intervention 0–5 weeks prior to RP and continue for 24-months following surgery. The 3 active intervention arms receive access to a web-portal and text messages, coaching calls, and other intervention resources (e.g., heart rate sensor and resistance bands and/or recipe booklet). Weekly exercise goals for the exercise intervention groups are 150 min moderate or 75 min vigorous aerobic exercise, 2 strength sessions, and 2 flexibility sessions. Diet intervention groups work with a dietitian to customize their goals (e.g., increase cruciferous vegetables, cooked tomatoes, healthy fats, fish; limit processed meats, whole milk). The primary endpoint is biochemical recurrence. Secondary endpoints include change in tumor biomarkers from biopsy to RP as well as patient-reported outcomes (e.g., quality-of-life), blood and urine biomarkers, and anthropometry at 0, 6, 12, and 24 months.ConclusionThis 4-arm RCT will examine the impact of change in exercise and diet (alone or in combination) on prostate cancer recurrence, biology, and quality-of-life.