European Palliative Care Research Centre (PRC), Department of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.
Cancer Clinic, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.
J Cachexia Sarcopenia Muscle. 2017 Oct;8(5):778-788. doi: 10.1002/jcsm.12201. Epub 2017 Jun 14.
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.
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。有人认为，恶病质的最佳治疗方法应该是多模式干预。本研究的主要目的是检查一种多模式干预（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）对不可治愈的肺癌或胰腺癌化疗患者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为多模式恶病质干预组或标准护理组。主要结局指标是通过招募、流失和对干预措施的依从性（>50%的患者接受>50%的治疗方案）进行评估。次要结局指标是体重、肌肉量、体力活动、安全性和生存率的变化。
共筛选了 399 例患者，最终纳入 46 例患者（11.5%）。25 例患者随机分为治疗组，21 例患者为对照组。41 例患者完成了研究（失访率为 11%）。塞来昔布、运动和营养补充剂的依从性分别为 76%、60%和 48%。由于样本量的原因，对体力活动或肌肉量没有统计学上的显著影响。干预组没有发生与治疗相关的严重不良事件，两组的生存率相似。
在不可治愈的肺癌或胰腺癌患者中，多模式恶病质干预是可行和安全的；然而，营养补充剂的依从性并不理想。目前正在进行一项 III 期研究，以全面评估干预措施的效果。
