Department of Medical Oncology, Amsterdam UMC, Vrije Universiteit, Cancer Center Amsterdam, P.O. Box 7057, 1081 HV, Amsterdam, the Netherlands; Department of Nutrition and Dietetics, Internal Medicine, Amsterdam UMC, Vrije Universiteit, P.O. Box 7057, 1081 HV, Amsterdam, the Netherlands.
Department of Nutrition and Dietetics, Internal Medicine, Amsterdam UMC, Vrije Universiteit, P.O. Box 7057, 1081 HV, Amsterdam, the Netherlands; Department of Nutrition and Dietetics, Faculty of Health, Nutrition and Sport, The Hague University of Applied Sciences, P.O. Box 13336, 2501 EH, The Hague, the Netherlands.
Clin Nutr. 2020 Oct;39(10):3005-3013. doi: 10.1016/j.clnu.2020.01.009. Epub 2020 Jan 29.
BACKGROUND & AIMS: A low muscle mass before start of treatment and loss of muscle mass during chemotherapy is related to adverse outcomes in patients with cancer. In this randomized controlled trial, the effect of nutritional counseling on change in muscle mass and treatment outcome in patients with metastatic colorectal cancer during first-line chemotherapy was studied.
Patients scheduled for first-line chemotherapy (n = 107) were randomly assigned to individualized nutritional counseling by a dietitian (NC) or usual care (UC). NC was aimed at sufficient protein- and energy intake, supported by oral supplements or enteral feeding if indicated. Furthermore, physical activity was encouraged. Outcomes were assessed at baseline (T0) and the time of the first (T1) and second (T2) regular follow-up computed tomography scans. The proportion of patients with a clinically relevant decrease in skeletal muscle area of ≥6.0 cm, measured by computed tomography, was the primary outcome. Secondary outcomes included body weight, quality of life, treatment toxicity and progression free and overall survival.
A total of 107 patients were enrolled (mean age, 65 years (SD, 11 years), 63% male). Mean change in skeletal muscle area from T0 till T1 was -2.5 (SD, 9.5) cm, with no difference between NC versus UC (p = 0.891). The proportion of patients with a clinically relevant decrease in skeletal muscle area of ≥6.0 cm did not differ (NC 30% versus UC 31%, p = 0.467). NC compared with UC had a significant positive effect on body weight (B coefficient 1.7, p = 0.045), progression free survival (p = 0.039) and overall survival (p = 0.046).
NC of patients undergoing chemotherapy for metastatic colorectal cancer had no effect on muscle mass. However, we found that NC may increase body weight and improve progression free survival and overall survival compared to UC in this group of patients. These findings need further evaluation in future clinical trials.
ClinicalTrials.gov NCT01998152; Netherlands Trial Register NTR4223.
治疗开始前肌肉量低和化疗期间肌肉量丢失与癌症患者的不良预后相关。在这项随机对照试验中，研究了营养咨询对转移性结直肠癌患者一线化疗期间肌肉量变化和治疗结果的影响。
计划接受一线化疗的患者（n=107）被随机分配接受营养师的个体化营养咨询（NC）或常规护理（UC）。NC 的目的是摄入足够的蛋白质和能量，如果需要，通过口服补充剂或肠内喂养来支持。此外，还鼓励进行身体活动。在基线（T0）和第一次（T1）和第二次（T2）常规计算机断层扫描（CT）随访时评估结局。通过 CT 测量的骨骼肌面积临床相关下降≥6.0cm 的患者比例是主要结局。次要结局包括体重、生活质量、治疗毒性以及无进展生存期和总生存期。
共纳入 107 例患者（平均年龄 65 岁（SD，11 岁），63%为男性）。从 T0 到 T1 ，骨骼肌面积的平均变化为-2.5（SD，9.5）cm，NC 与 UC 之间无差异（p=0.891）。骨骼肌面积临床相关下降≥6.0cm 的患者比例无差异（NC 30%与 UC 31%，p=0.467）。与 UC 相比，NC 对体重有显著的正向影响（B 系数 1.7，p=0.045）、无进展生存期（p=0.039）和总生存期（p=0.046）。
接受转移性结直肠癌化疗的患者接受营养咨询对肌肉量没有影响。然而，我们发现，与 UC 相比，NC 可能会增加体重，并改善这组患者的无进展生存期和总生存期。这些发现需要在未来的临床试验中进一步评估。
ClinicalTrials.gov NCT01998152；荷兰试验注册处 NTR4223。
