Nutritional advice in older patients at risk of malnutrition during treatment for chemotherapy: a two-year randomized controlled trial.
Nutritional advice in older patients at risk of malnutrition during treatment for chemotherapy: a two-year randomized controlled trial.
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DOI：
10.1371/journal.pone.0108687
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发表时间：
2014
期刊：
影响因子：
3.7
通讯作者：
Fonck M
中科院分区：
文献类型：
--
作者：
Bourdel-Marchasson I;Blanc-Bisson C;Doussau A;Germain C;Blanc JF;Dauba J;Lahmar C;Terrebonne E;Lecaille C;Ceccaldi J;Cany L;Lavau-Denes S;Houede N;Chomy F;Durrieu J;Soubeyran P;Senesse P;Chene G;Fonck M
我们测试了在化疗期间有营养不良风险的老年患者中增加摄入量的饮食建议与常规护理对一年死亡率的影响。我们进行了一项多中心、开放标签、干预性、分层（中心）、平行随机对照试验，比例为1∶1，随访2年。患者年龄≥ 70岁，接受实体瘤化疗，有营养不良风险（MNA，微型营养评估17-23.5）。干预措施包括饮食咨询，目的是通过面对面的讨论，针对主要营养症状，与常规护理相比，实现30千卡/公斤体重/天的能量摄入和1.2克蛋白质/公斤/天。在化疗期间进行了6次访谈，为期3至6个月。主要终点为1年死亡率，次要终点为2年死亡率、毒性和化疗结局。在2007年4月至2010年3月期间，我们随机分配了341例患者，并对336例患者进行了分析：平均（标准差）年龄为78.0岁（4.9），51.2%为男性，平均MNA为20.2（2.1）。两组中癌症类型的分布相似;最常见的是结肠癌（22.4%）、淋巴瘤（14.9%）、肺癌（10.4%）和胰腺癌（17.0%）。两组都增加了他们的饮食摄入量，但干预的程度更大（p<0.01）。在第二次访视时，干预组有57例（40.4%）患者达到了能量目标，66例（46.8%）患者达到了蛋白质目标，而对照组分别为13例（13.5%）和20例（20.8%）。143例患者（42.56%）在第一年内死亡，根据干预措施没有差异（p = 0.79）。 两组的营养状况变化无差异，对化疗的反应也相似。早期饮食咨询在增加摄入量方面是有效的，但对死亡率或次要结局没有有益的影响。癌症恶病质抗肿瘤药可能解释这种缺乏效果。ClinicalTrials.gov NCT00459589
We tested the effect of dietary advice dedicated to increase intake in older patients at risk for malnutrition during chemotherapy, versus usual care, on one-year mortality. We conducted a multicentre, open-label interventional, stratified (centre), parallel randomised controlled trial, with a 1∶1 ratio, with two-year follow-up. Patients were aged 70 years or older treated with chemotherapy for solid tumour and at risk of malnutrition (MNA, Mini Nutritional Assessment 17–23.5). Intervention consisted of diet counselling with the aim of achieving an energy intake of 30 kCal/kg body weight/d and 1.2 g protein/kg/d, by face-to-face discussion targeting the main nutritional symptoms, compared to usual care. Interviews were performed 6 times during the chemotherapy sessions for 3 to 6 months. The primary endpoint was 1-year mortality and secondary endpoints were 2-year mortality, toxicities and chemotherapy outcomes. Between April 2007 and March 2010 we randomised 341 patients and 336 were analysed: mean (standard deviation) age of 78.0 y (4·9), 51.2% male, mean MNA 20.2 (2.1). Distribution of cancer types was similar in the two groups; the most frequent were colon (22.4%), lymphoma (14.9%), lung (10.4%), and pancreas (17.0%). Both groups increased their dietary intake, but to a larger extent with intervention (p<0.01). At the second visit, the energy target was achieved in 57 (40.4%) patients and the protein target in 66 (46.8%) with the intervention compared respectively to 13 (13.5%) and 20 (20.8%) in the controls. Death occurred during the first year in 143 patients (42.56%), without difference according to the intervention (p = 0.79). No difference in nutritional status changes was found. Response to chemotherapy was also similar between the groups. Early dietary counselling was efficient in increasing intake but had no beneficial effect on mortality or secondary outcomes. Cancer cachexia antianabolism may explain this lack of effect. ClinicalTrials.gov NCT00459589
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