A randomized phase II feasibility trial of a multimodal intervention for the management of cachexia in lung and pancreatic cancer.

A randomized phase II feasibility trial of a multimodal intervention for the management of cachexia in lung and pancreatic cancer.
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DOI:
10.1002/jcsm.12201
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发表时间:
2017-10
期刊:
Journal of cachexia, sarcopenia and muscle
影响因子:
--
通讯作者:
Kaasa S
Kaasa S
中科院分区:
其他
文献类型:
--
作者:
Solheim TS;Laird BJA;Balstad TR;Stene GB;Bye A;Johns N;Pettersen CH;Fallon M;Fayers P;Fearon K;Kaasa S

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癌症恶病质是一种体重减轻(包括肌肉和脂肪)、厌食和身体功能下降的综合征。有人建议恶病质的最佳治疗应该是多模式干预。本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、运动和抗炎药物:塞来昔布)治疗接受化疗的无法治愈的肺癌或胰腺癌患者的癌症恶病质的可行性和安全性。接受两个周期标准化疗的患者被随机分配到多模式恶病质干预组或标准治疗组。主要结果指标是通过招募、流失和干预依从性(> 50%的患者中> 50%的组分)评估的可行性。关键次要结局是体重、肌肉量、体力活动、安全性和生存率的变化。筛选了399例患者,招募了46例患者(11.5%)。25例患者随机接受治疗,21例作为对照。41人完成了研究(脱落率11%)。塞来昔布组对干预的各个组成部分的依从性为76%,运动组为60%,营养补充剂组为48%。正如样本量所预期的那样,对体力活动或肌肉质量没有统计学显著影响。两组间无干预相关严重不良事件,生存率相似。多模式恶病质干预在不可治愈的肺癌或胰腺癌患者中是可行和安全的;然而,营养补充剂的依从性不佳。目前正在进行第三阶段研究,以全面评估干预措施的效果。
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. 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. 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. 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.
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