Brown Justin C, Brighton Elizabeth, Campbell Nancy, McCleary Nadine J, Abrams Thomas A, Cleary James M, Enzinger Peter C, Ng Kimmie, Rubinson Douglas, Wolpin Brian M, Yurgelun Matthew B, Meyerhardt Jeffrey A
Cancer Metabolism Program, Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.
Department of Genetics, Louisiana State University Health Sciences Center, New Orleans, Louisiana, USA.
BMJ Open Sport Exerc Med. 2022 May 30;8(2):e001353. doi: 10.1136/bmjsem-2022-001353. eCollection 2022.
This study determined the feasibility of delivering a 12-week structured physical activity programme during chemotherapy to older adults recently diagnosed with metastatic gastrointestinal (GI) cancer.
This study used a single-cohort design. Older adults (aged ≥65 years) diagnosed with metastatic oesophageal, gastric, pancreatic or colorectal cancer who planned to initiate chemotherapy were enrolled. The physical activity programme included a combination of aerobic, flexibility, strength and balance modalities delivered by a certified cancer exercise trainer during chemotherapy infusion appointments, then translated and sustained at home by participants. The co-primary endpoints included: (1) accrual of 20 participants in 12 months and (2) physical activity adherence of ≥50%.
Between March and October 2018, 29 participants were screened, and 20 were enrolled within 12 months (recruitment rate: 69% (90% CI: 55% to 83%); p<0.001), meeting the first co-primary endpoint. The median age of participants was 73.3 years (IQR: 69.3-77.2). At week 12, 67% (90% CI: 48% to 85%) of participants adhered to ≥50% of the prescribed physical activity (p=0.079 (statistically significant)), meeting the second co-primary endpoint. From baseline to week 12, accelerometer-measured light-intensity and moderate-intensity to vigorous-intensity physical activity increased by 307.4 (95% CI: 152.6 to 462.2; p<0.001) and 25.0 min per week (95% CI: 9.9 to 40.1; p=0.001), respectively. There were no serious or unexpected adverse events. The median overall survival was 16.2 months (8.4-22.4).
These results establish the feasibility of a larger scale randomised controlled trial that enrols older adults with metastatic GI cancer and delivers a structured physical activity programme during chemotherapy.
NCT03331406.
本研究确定了在化疗期间为近期诊断为转移性胃肠道（GI）癌的老年人提供为期12周的结构化体育活动计划的可行性。
本研究采用单队列设计。纳入计划开始化疗的、年龄≥65岁、诊断为转移性食管癌、胃癌、胰腺癌或结直肠癌的老年人。体育活动计划包括有氧运动、柔韧性、力量和平衡训练的组合，由一名认证的癌症运动训练师在化疗输液期间进行指导，然后由参与者在家中进行转化和维持。共同主要终点包括：（1）12个月内招募20名参与者；（2）体育活动依从性≥50%。
2018年3月至10月期间，共筛查了29名参与者，12个月内招募了20名（招募率：69%（90%CI：55%至83%）；p<0.001），达到了第一个共同主要终点。参与者的中位年龄为73.3岁（IQR：69.3-77.2）。在第12周时，67%（90%CI：48%至85%）的参与者坚持了≥50%的规定体育活动（p=0.079（具有统计学意义）），达到了第二个共同主要终点。从基线到第12周，通过加速度计测量，轻度强度以及中度至剧烈强度的体育活动分别增加了307.4分钟/周（95%CI：152.6至462.2；p<0.001）和25.0分钟/周（95%CI：9.9至40.1；p=0.001）。没有严重或意外的不良事件。中位总生存期为16.2个月（8.4-22.4）。
这些结果证实了开展一项更大规模随机对照试验的可行性，该试验将纳入患有转移性胃肠道癌的老年人，并在化疗期间提供结构化体育活动计划。
NCT0****。 （此处原文注册号最后几位未完整显示）
