Section on Hematology and Oncology, Wake Forest University School of Medicine, Winston Salem, NC, United States of America.
Division of Public Health Sciences, Wake Forest University School of Medicine, Winston Salem, NC, United States of America.
J Geriatr Oncol. 2023 May;14(4):101478. doi: 10.1016/j.jgo.2023.101478. Epub 2023 Mar 27.
Fatigue is a prevalent symptom among both cancer survivors and older adults. Negative consequences of fatigue include increased sedentary behavior, decreased physical activity and function, and lower quality of life. Few pharmacologic interventions improve fatigue. Our preclinical and clinical data show promising effects of a muscadine grape extract supplement (MGES) on oxidative stress, mitochondrial bioenergetics, the microbiome, and the symptom of fatigue. This pilot study seeks to translate these observations to cancer survivorship by testing the preliminary effect of MGE supplementation on older adult cancer survivors with self-reported fatigue.
We designed a double-blinded placebo-controlled pilot study to evaluate preliminary efficacy of MGE supplementation versus placebo on fatigue among older adult cancer survivors (aged ≥65 years) who report baseline fatigue. Sixty-four participants will be enrolled and randomized 1:1 to twice daily MGES (four tablets twice daily) versus placebo for 12 weeks. The primary outcome is change in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue score from baseline to 12 weeks. Secondary outcomes are change in self-reported physical function, physical fitness (6-min walk test), self-reported physical activity, global quality of life (QOL), and the Fried frailty index. Correlative biomarker assays will assess changes in 8-hydroxy-2 deoxyguanosine, peripheral blood mitochondrial function, inflammatory markers, and the gut microbiome.
This pilot study builds on preclinical and clinical observations to estimate effects of MGE supplementation on fatigue, physical function, QOL, and biologic correlates in older adult cancer survivors. Trial registration #: CT.govNCT04495751; IND 152908.
疲劳是癌症幸存者和老年人普遍存在的症状。疲劳的负面影响包括增加久坐行为、减少身体活动和功能以及降低生活质量。很少有药物干预措施能改善疲劳。我们的临床前和临床数据显示，麝香葡萄提取物补充剂（MGES）对氧化应激、线粒体生物能学、微生物组和疲劳症状有很好的效果。这项初步研究旨在通过测试 MGES 补充剂对报告有疲劳症状的老年癌症幸存者的初步效果，将这些观察结果转化为癌症生存者。
我们设计了一项双盲安慰剂对照的初步研究，以评估 MGES 补充剂与安慰剂对报告有基线疲劳的老年癌症幸存者（年龄≥65 岁）疲劳的初步疗效。将招募 64 名参与者，并随机分为 1:1 接受每日两次 MGES（每日 4 片）或安慰剂治疗 12 周。主要结局是从基线到 12 周时患者报告的结局测量信息系统（PROMIS）疲劳评分的变化。次要结局是自我报告的身体功能、身体适应性（6 分钟步行测试）、自我报告的身体活动、总体生活质量（QOL）和 Fried 衰弱指数的变化。相关生物标志物检测将评估 8-羟基-2 脱氧鸟苷、外周血线粒体功能、炎症标志物和肠道微生物组的变化。
这项初步研究基于临床前和临床观察，估计 MGES 补充剂对老年癌症幸存者疲劳、身体功能、QOL 和生物学相关性的影响。试验注册号：CT.govNCT04495751；IND 152908。
