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首页> 外文期刊>BMC Cancer >Beta-hydroxy beta-methylbutyrate/arginine/glutamine (HMB/Arg/Gln) supplementation to improve the management of cachexia in patients with advanced lung cancer: an open-label, multicentre, randomised, controlled phase II trial (NOURISH)
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Beta-hydroxy beta-methylbutyrate/arginine/glutamine (HMB/Arg/Gln) supplementation to improve the management of cachexia in patients with advanced lung cancer: an open-label, multicentre, randomised, controlled phase II trial (NOURISH)

机译：β-羟基β-甲基丁酸酯/精氨酸/谷氨酰胺（HMB / ARG / GLN）补充，以改善晚期肺癌患者的恶毒症管理：开放标签，多期，随机，受访期第二次试验（滋养）

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Cancer cachexia causes significant morbidity and mortality in advanced lung cancer patients. Clinical benefit of β-hydroxy-β-methylbutyrate, arginine, and glutamine (HMB/Arg/Gln) was assessed in newly diagnosed patients. NOURISH, a prospective, two-arm, open-label, multi-centre, randomised controlled phase II trial compared cachexia in patients who received HMB/Arg/Gln with those who did not. All patients received structured nutritional, exercise and symptom control via a Macmillan Durham Cachexia Pack. Conducted in five UK centres, patients aged ?18?years, with newly diagnosed advanced small cell lung cancer (SCLC) or non-small cell lung cancer (NSCLC), who were able to take oral nutrition, with a performance status of 0-to-2 and a life expectancy ?4?months were eligible for trial entry. Patients suitable for treatment with curative intent were ineligible. The trial was designed as a signal-seeking pilot study with target recruitment of 96 patients. One-to-one randomisation was stratified by diagnosis (SCLC or NSCLC), stage of disease (locally advanced or metastatic) and performance status. The primary outcome measure was treatment success defined as a patient being alive without significant loss of lean body mass (not ?5%) by 12?weeks. Secondary outcome measures included quality of life. Between February-2012 and February-2013, 38 patients were recruited, 19 to each arm. Baseline characteristics were balanced. The trial was halted due to slow accrual and partial adherence. Trial data demonstrated no evidence of treatment benefit. No serious adverse events were reported during the trial. Further evaluation of HMB/Arg/Gln in this setting could not be recommended on the basis of this trial. ISRCTN registry: 39911673; 14-Apr-2011 https://doi.org/10.1186/ISRCTN39911673 .
机译：癌症恶病症在晚期肺癌患者中引起显着的发病率和死亡率。在新诊断的患者中评估了β-羟基-β-甲基丁酸酯，精氨酸和谷氨酰胺（HMB / ARG / GLN）的临床益处。滋养，前瞻性，双臂，开放标签，多中心，随机对照第二阶段试验与那些没有那些没有的人接受HMB / ARG / GLN的患者进行了比较的恶化的恶病质。所有患者均通过Macmillan Durham Cachexia包接受结构化营养，运动和症状控制。在五个英国中心进行，患者效果，年龄较高，患者18岁;年份，具有新诊断的晚期小细胞肺癌（SCLC）或非小细胞肺癌（NSCLC），他能够进行口服营养，具有绩效状况0-to-2和预期寿命＆？4？几个月有资格进行试用。适合用治疗意图治疗的患者不合格。该试验设计为寻求信号试点研究，目标招募96名患者。通过诊断（SCLC或NMSCLC），疾病阶段（局部先进或转移）和性能状况一对一的随机化。主要结果措施是治疗成功定义为患者活着的患者没有大量损失（不＆ 5％）12？周。次要结果措施包括生命质量。 2012年2月至2013年2月至2013年间，招募了38名患者，每只臂19例。基线特征是平衡的。由于慢速和部分依从性，试验被停止。试验数据证明没有治疗效益的证据。审判期间没有报告严重的不良事件。在此设置中进一步评估HMB / ARG / GLN，不能根据本试验建议。 ISRCTN注册表：39911673; 2011年4月14日 - 2011年HTTPS：//Doi.org/10.1186/ISRCTN39911673。

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