Resistance training and protein supplementation in patients with incurable gastroesophageal cancer: a randomized feasibility trial.
完整摘要 · 中文译文
目的：癌症恶病质与无法治愈的胃食管癌患者体力活动能力、生活质量和生存期的下降相关。抗阻训练和蛋白质补充有可能改善这些结局。在无法治愈的胃食管癌治疗期间，包含抗阻训练和蛋白质补充的干预是否可行尚不清楚。 方法：这是一项开放标签、平行分组、两臂、随机对照可行性试验。计划接受一线化疗的无法治愈的胃食管癌患者按2：1随机分配至每周三次抗阻训练联合每日蛋白质补充组或对照组。主要结局为可行性，通过招募率、保留率、依从性和危害进行评估。次要结局包括身体成分、体力活动能力、生活质量和治疗耐受性。 结果：在106例潜在合格患者中，20例参与者（5例女性和15例男性，平均年龄65岁）被随机分配，招募率为19%。18例参与者完成了试验，保留率为90%。抗阻训练课程和蛋白质补充剂的中位（第25；第75百分位数）依从性分别为63%（43；77）和39%（17；76）。五例参与者（38%）同时达到了两种干预的最低可行性标准。未发生与干预相关的严重不良事件。我们未发现组间在身体成分、体力活动能力、生活质量或治疗耐受性方面存在差异。 结论：抗阻 在不可治愈的胃食管癌患者中，由于入组率低且对蛋白质补充的依从性低，一线化疗期间联合蛋白质补充的训练不可行。 试验注册：ClinicalTrials.gov NCT05650827。研究注册日期2022-12-12。
完整摘要 · 英文原文
PURPOSE: Cancer cachexia is associated with reduced physical performance, quality of life, and survival in patients with incurable gastroesophageal cancer. Resistance training and protein supplementation have the potential to improve these outcomes. Whether an intervention comprising resistance training and protein supplementation is feasible during treatment for incurable gastroesophageal cancer is not known. METHODS: This was an open-label, parallel-group, two-arm, randomized controlled feasibility trial. Patients with incurable gastroesophageal cancer scheduled to undergo first-line chemotherapy were randomized 2:1 to resistance training three times per week and daily protein supplementation or to control. The primary outcome, feasibility, was assessed by recruitment, retention, adherence, and harms. Secondary outcomes included body composition, physical performance, quality of life, and treatment tolerability. RESULTS: Out of 106 potentially eligible patients, 20 participants (5 female and 15 male, mean age 65) were randomized yielding a recruitment rate of 19%. 18 participants completed the trial with a retention rate of 90%. Median (25th; 75th percentile) adherence to the resistance training sessions and to the protein supplements was 63% (43; 77) and 39% (17; 76), respectively. Five participants (38%) met the minimum feasibility criteria of both interventions. No serious adverse events related to the intervention occurred. We found no between-group differences in body composition, physical performance, quality of life, or treatment tolerability. CONCLUSION: Resistance training combined with protein supplementation was not feasible during first-line chemotherapy in patients with incurable gastroesophageal cancer due to low accrual and low adherence to protein supplementation. TRIAL REGISTRATION: ClinicalTrials.gov NCT05650827. Study registration date 2022-12-12.
摘要 待译
PURPOSE: Cancer cachexia is associated with reduced physical performance, quality of life, and survival in patients with incurable gastroesophageal cancer. Resistance training and protein supplementation have the potential to improve these outcomes. Whether an intervention comprising resistance training and protein supplementation is feasible during treatment for incurable gastroesophageal cancer is not known. METHODS: This was an open-label, parallel-group, two-arm, randomized controlled feasibility trial.…