Human Nutrition Research Unit, Department of Agricultural, Food & Nutritional Sciences, University of Alberta, Edmonton, AB, Canada.
Department of Oncology, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.
Clin Nutr ESPEN. 2021 Feb;41:175-185. doi: 10.1016/j.clnesp.2020.11.016. Epub 2020 Dec 24.
Severe muscle mass (MM) loss is a defining feature of cancer observed across all types and stages of disease and is an independent predictor of poor clinical outcomes including higher incidences of chemotherapy toxicity and decreased survival. Protein is essential to build MM, yet the optimal amount for preventing or treating muscle loss in patients with cancer remains undefined.
The Protein Recommendation to Increase Muscle (PRIMe) study is a single-center, two-armed, parallel, randomized, controlled pilot trial that assesses the feasibility of utilizing a high protein (HP) diet to positively impact clinical outcomes in people undergoing chemotherapy to treat colorectal cancer. Forty patients with newly diagnosed stage II-IV colorectal cancer who are scheduled to receive chemotherapy will be included. Participants are randomly assigned to a HP or normal protein (NP) diet for twelve weeks. The HP and NP groups receive nutrition recommendations to achieve 2.0 g of protein per kilogram of body weight per day (g∙kg∙d) and 1.0 g⋅kg⋅d, respectively. These values refer to the upper and lower recommended range of protein intake for people with cancer. Energy recommendations are based on measured energy expenditure. Assessments are completed within two weeks of starting chemotherapy (baseline), at week 6, and at week 12. Changes to skeletal MM, physical function, anthropometrics, body composition, muscle strength, physical activity, energy metabolism, metabolic markers, nutritional status, quality of life, readiness to change and psychosocial determinants of behavioural change are assessed between the HP and NP groups. Feasibility of the nutritional intervention is assessed by change in MM as a surrogate marker.
This evidence-based study investigates the feasibility of increasing protein intake following a diagnosis of cancer on clinical outcomes during treatment for colorectal cancer. This study will inform larger trials assessing the impact of increasing protein intake in cancer to determine their importance and integration into standard clinical care for people with cancer.
严重的肌肉质量（MM）损失是癌症的一个显著特征，在所有类型和疾病阶段都有观察到，并且是不良临床结局的独立预测因素，包括化疗毒性发生率更高和生存率降低。蛋白质对于构建 MM 至关重要，但在癌症患者中预防或治疗肌肉损失的最佳蛋白质摄入量仍未确定。
蛋白质推荐增加肌肉（PRIMe）研究是一项单中心、双臂、平行、随机、对照的初步试验，评估高蛋白质（HP）饮食在接受化疗治疗结直肠癌的人群中积极影响临床结局的可行性。将纳入 40 名新诊断为 II-IV 期结直肠癌且计划接受化疗的患者。参与者被随机分配到 HP 或正常蛋白质（NP）饮食组，为期 12 周。HP 和 NP 组分别接受营养建议，以实现每天每公斤体重 2.0 克（g·kg·d）和 1.0 g·kg·d 的蛋白质摄入量。这些值指的是癌症患者蛋白质摄入量的建议上限和下限。能量建议基于测量的能量消耗。在开始化疗的两周内（基线）、第 6 周和第 12 周进行评估。在 HP 和 NP 组之间评估骨骼 MM、身体功能、人体测量学、身体成分、肌肉力量、身体活动、能量代谢、代谢标志物、营养状况、生活质量、改变意愿和行为改变的心理社会决定因素的变化。通过 MM 的变化评估营养干预的可行性，作为替代标志物。
本基于证据的研究调查了在结直肠癌治疗期间诊断出癌症后增加蛋白质摄入对临床结局的影响的可行性。这项研究将为评估增加蛋白质摄入对癌症的影响的更大规模试验提供信息，以确定其重要性并将其纳入癌症患者的标准临床护理。
