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首页> 外文期刊>Journal of Cachexia, Sarcopenia and Muscle >A randomized phase II feasibility trial of a multimodal intervention for the management of cachexia in lung and pancreatic cancer
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A randomized phase II feasibility trial of a multimodal intervention for the management of cachexia in lung and pancreatic cancer

机译：一项多模式干预治疗肺癌和胰腺癌恶病质的随机II期可行性试验

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Abstract Background Cancer cachexia is a syndrome of weight loss (including muscle and fat), anorexia, and decreased physical function. It has been suggested that the optimal treatment for cachexia should be a multimodal intervention. The primary aim of this study was to examine the feasibility and safety of a multimodal intervention (n-3 polyunsaturated fatty acid nutritional supplements, exercise, and anti-inflammatory medication: celecoxib) for cancer cachexia in patients with incurable lung or pancreatic cancer, undergoing chemotherapy. Methods Patients receiving two cycles of standard chemotherapy were randomized to either the multimodal cachexia intervention or standard care. Primary outcome measures were feasibility assessed by recruitment, attrition, and compliance with intervention (>50% of components in >50% of patients). Key secondary outcomes were change in weight, muscle mass, physical activity, safety, and survival. Results Three hundred and ninety-nine were screened resulting in 46 patients recruited (11.5%). Twenty five patients were randomized to the treatment and 21 as controls. Forty-one completed the study (attrition rate 11%). Compliance to the individual components of the intervention was 76% for celecoxib, 60% for exercise, and 48% for nutritional supplements. As expected from the sample size, there was no statistically significant effect on physical activity or muscle mass. There were no intervention-related Serious Adverse Events and survival was similar between the groups. Conclusions A multimodal cachexia intervention is feasible and safe in patients with incurable lung or pancreatic cancer; however, compliance to nutritional supplements was suboptimal. A phase III study is now underway to assess fully the effect of the intervention.
机译：摘要背景恶病质是一种体重减轻（包括肌肉和脂肪），厌食症和身体机能下降的综合征。有人建议，恶病质的最佳治疗方法应该是多模式干预。这项研究的主要目的是检查多模式干预（n-3多不饱和脂肪酸营养补充剂，运动和抗炎药：塞来昔布）在无法治愈的肺癌或胰腺癌患者中进行癌症恶病质的可行性和安全性。化学疗法。方法将接受两个标准化疗周期的患者随机分为多模式恶病质干预或标准护理。主要结果指标通过招募，减员和干预依从性评估可行性（> 50％的患者中> 50％的成分）。主要的次要结局是体重，肌肉质量，体育活动，安全性和生存率的变化。结果筛选了399例患者，共招募46例患者（11.5％）。 25例患者被随机分配至治疗组，21例作为对照组。共有41人完成了研究（损耗率11％）。塞来昔布对干预的各个组成部分的依从性为76％，运动为60％，营养补充剂为48％。正如样本量所期望的，对身体活动或肌肉质量没有统计学上的显着影响。没有干预相关的严重不良事件，两组之间的生存率相似。结论多模式恶病质干预对于不治之肺癌或胰腺癌患者是可行，安全的。但是，对营养补充剂的依从性欠佳。目前正在进行III期研究，以全面评估干预措施的效果。

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