一项有氧运动治疗结直肠癌的随机试验：原理、设计、招募和运动依从性结果。
A randomized trial of aerobic exercise in colorectal cancer: Rationale, design, recruitment, and exercise adherence results.
机构信息
Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA 70808, USA.
LSU Health Sciences Center, New Orleans School of Public Health, Louisiana Tumor Registry, 2020 Gravier St., New Orleans, LA 70112, USA.
出版信息
Contemp Clin Trials. 2024 Nov;146:107702. doi: 10.1016/j.cct.2024.107702. Epub 2024 Oct 1.
BACKGROUND
Physical activity is associated with improved disease-free survival in colorectal cancer survivors. This report describes the purpose, design, recruitment, and exercise adherence results of the National Cancer Institute (NCI)-sponsored Exercise and Colorectal Cancer Treatment (EXACT) trial.
METHODS
The primary objective of the EXACT trial is to determine if randomization to 150 min per week of moderate-intensity aerobic exercise reduces systemic inflammation among stage I-III colorectal cancer survivors compared with a waitlist control group over 12 weeks. Participants were provided with an in-home treadmill and heart rate monitor. Characteristics associated with randomization were identified using χ or Fisher's exact test for categorical variables and t-tests or analysis of covariance (ANCOVA). Exercise adherence was calculated as the total minutes exercised by total minutes prescribed.
RESULTS
Between August 2019 and February 2023, 3082 colorectal cancer survivors were invited to participate, 89 were screened, and 60 were randomized to the study protocol. Younger age (P = 0.02), female sex (P = 0.002), white race (P = 0.01), proximal time since tumor resection (P = 0.02), and regional tumor stage (P < 0.001) were associated with study participation. Average exercise adherence was 92.2 % (95 % CI: 85.5, 98.8) and all study participants achieved ≥80 % exercise adherence. Endpoint data collection was completed for all participants in May 2023.
CONCLUSION
The results from the EXACT trial will characterize the changes that occur from exercise to advance our understanding of the biological mechanisms by which exercise may prevent tumor recurrence and death in colorectal cancer survivors.
背景
身体活动与结直肠癌幸存者无病生存率的提高有关。本报告介绍了美国国家癌症研究所（NCI）赞助的运动与结直肠癌治疗（EXACT）试验的目的、设计、招募情况以及运动依从性结果。
方法
EXACT 试验的主要目的是确定与等待对照组相比，每周 150 分钟中等强度有氧运动的随机分组是否能在 12 周内降低 I-III 期结直肠癌幸存者的全身炎症。参与者获得了家用跑步机和心率监测器。使用卡方检验或 Fisher 确切检验进行分类变量分析，t 检验或协方差分析（ANCOVA）进行 t 检验或协方差分析（ANCOVA），以确定与随机分组相关的特征。运动依从性按规定运动总分钟数计算。
结果
2019 年 8 月至 2023 年 2 月，共邀请 3082 名结直肠癌幸存者参加，其中 89 人接受了筛查，60 人被随机分配到研究方案中。较年轻的年龄（P=0.02）、女性（P=0.002）、白人（P=0.01）、肿瘤切除后时间较短（P=0.02）和区域肿瘤分期（P<0.001）与研究参与有关。平均运动依从率为 92.2%（95%可信区间：85.5%，98.8%），所有研究参与者均达到≥80%的运动依从率。所有参与者均于 2023 年 5 月完成了终点数据收集。
结论
EXACT 试验的结果将描述运动带来的变化，以深入了解运动可能预防结直肠癌幸存者肿瘤复发和死亡的生物学机制。
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