Effects of a Supplementation With a Mixture of Essential Amino Acids on Enhancing the Number of Circulating Lymphocytes and Improveing the Tolerance to Chemotherapy Treatment in Patients With Advanced Gastroinmtestinal Malignances the LEGO Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Exit from lymphopenia
研究概览
简要总结
LEGO is single center double-blind randomized trial aimed at testing the efficacy of an essential ammino acid (EAA) supplementation in improving the absolute count of peripheral lymphocytes and the tolerance to chemotherapy in patients with advanced gastrointestinal malignancies not candidates to immune check-point inhibitors containing regimens.
详细描述
The aim of the study is to verify that, in lymphopenic patients, AAE supplementation leads to an increase in lymphocytes circulating in the blood. In particular, at the end of treatment, in patients with lymphocytes < 29.7% of the total number of white blood cells, we want to observe the disappearance of lymphopenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of epithelial neoplasia of the gastrointestinal tract in advanced stage with indication for first-line chemotherapy for palliative purposes and with circulating lymphocytes < 29.7% of the number total white blood cells in the blood.
- •ECOG PS ≤ 2
- •start of first-line palliative chemotherapy agreement with AIOM guidelines.
- •adequate nutritional counseling carried out before starting of the treatment
- •willing to participate by providing written informed consent
排除标准
- •age < 18 years
- •current or indicated artificial nutrition
- •gluten intolerance
- •prediction of use of granulocyte growth factors
- •confirmed diagnosis of COPD, chronic heart failure, insufficiency chronic kidney disease, chronic liver failure, collagen disease, diseases endocrine, insulin-dependent diabetes, malignancy in other locations. All these conditions are associated with documented alterations in the plasma profile of amino acids and potentially of subsets of circulating T lymphocytes.
研究组 & 干预措施
Isocaloric placebo
干预措施: Isocaloric placebo (Other)
Sperimental
干预措施: EAA supplementation (Dietary Supplement)
结局指标
主要结局
Exit from lymphopenia
时间窗: 60 days
Proportion of patients exceeding the lymphopenia threshold level of 29.7%.
次要结局
- The change in the % of lymphocytes over time(0, 30, 60, 90 days)
- The percentage of chemotherapy dose administered compared to that expected for the patients.(60 days)
- The proportion of patients with G3-G5 toxicity(60 days)
- plasma aminoacids composition chang during treatment(60 days)