L-Carnitine Supplementation for the Management of Fatigue in Patients With Cancer: An Eastern Cooperative Oncology Group Phase III, Randomized, Double-Blind, Placebo-Controlled Trial
L-Carnitine Supplementation for the Management of Fatigue in Patients With Cancer: An Eastern Cooperative Oncology Group Phase III, Randomized, Double-Blind, Placebo-Controlled Trial
复制标题
DOI：
10.1200/jco.2011.40.2180
复制
发表时间：
2012-11-01
影响因子：
45.3
通讯作者：
Fisch, Michael J.
中科院分区：
文献类型：
--
作者：
Cruciani, Ricardo A.;Zhang, Jenny J.;Fisch, Michael J.
目的左旋肉碱是一种流行的补充和替代医学产品，癌症患者使用它来治疗疲劳，这是该患者群体中最常见的症状。本研究的目的是确定左旋肉碱补充剂治疗癌症患者疲劳的疗效。 患者和方法在这项双盲、安慰剂对照试验中，患有侵袭性恶性肿瘤和疲劳的患者被随机分配接受 2 g/d 口服左旋肉碱补充剂或匹配的安慰剂。主要终点是使用简短疲劳量表 (BFI) 从基线到第 4 周的平均每日疲劳变化。结果 376 名患者被随机分配接受左旋肉碱补充剂或安慰剂治疗。补充左旋肉碱导致第 4 周时肉碱血浆水平显着增加。与基线相比，使用 BFI 测量的主要结局疲劳，双臂均有所改善（左旋肉碱：-0.96，95% CI，-1.32 至 -0.60；安慰剂：-1.11，95% CI -1.44 至 -0.78）。各组之间没有统计学上的显着差异 (P = .57)。次要结果，包括通过慢性病治疗疲劳仪器功能评估测量的疲劳、抑郁和疼痛，在手臂之间没有显示出显着差异。对基线时缺乏肉碱的患者进行的单独分析并未显示补充左旋肉碱后疲劳或其他结果有统计学显着改善。 结论 补充 2 克左旋肉碱 4 周并没有改善患有侵袭性恶性肿瘤且体能状态良好的患者的疲劳。 J 临床肿瘤杂志 30：3864-3869。 (C) 2012 年美国临床肿瘤学会
PurposeL-carnitine, a popular complementary and alternative medicine product, is used by patients with cancer for the treatment of fatigue, the most commonly reported symptom in this patient population. The purpose of this study was to determine the efficacy of L-carnitine supplementation as a treatment for fatigue in patients with cancer.Patients and MethodsIn this double-blind, placebo-controlled trial, patients with invasive malignancies and fatigue were randomly assigned to either 2 g/d of L-carnitine oral supplementation or matching placebo. The primary end point was the change in average daily fatigue from baseline to week 4 using the Brief Fatigue Inventory (BFI).ResultsThree hundred seventy-six patients were randomly assigned to treatment with L-carnitine supplementation or placebo. L-carnitine supplementation resulted in significant carnitine plasma level increase by week 4. The primary outcome, fatigue, measured using the BFI, improved in both arms compared with baseline (L-carnitine: -0.96, 95% CI, -1.32 to -0.60; placebo: -1.11, 95% CI -1.44 to -0.78). There were no statistically significant differences between arms (P = .57). Secondary outcomes, including fatigue measured by the Functional Assessment of Chronic Illness Therapy-Fatigue instrument, depression, and pain, did not show significant difference between arms. A separate analysis of patients who were carnitine-deficient at baseline did not show statistically significant improvement in fatigue or other outcomes after L-carnitine supplementation.ConclusionFour weeks of 2 g of L-carnitine supplementation did not improve fatigue in patients with invasive malignancies and good performance status. J Clin Oncol 30: 3864-3869. (C) 2012 by American Society of Clinical Oncology