EAT-ING: Enhancing Anticancer Treatment Safety Via Immunomodulatory Nutritional Support in Advanced Gastrointestinal Cancers: A Single-Center Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 88
- 主要终点
- Absolute risk difference between study arms in the incidence of grade ≥ 3 AEs.
研究概览
简要总结
The use of immunomodulants in patients with GI cancer has been progressively gaining attention in the last years, as a high-calorie-high-protein nutritional blend enriched in immunonutrients has shown efficacy in several studies in reducing the risk of post-operative complications and the length of stay of patients undergoing major cancer surgery.
The guidelines for the nutritional management of patients with cancer agree on the utility of nutritional support, whenever it is necessary, to improve clinical outcomes, and the efficacy and tolerability of treatments.
To our knowledge, this is among the first clinical trial specifically designed to evaluate the role of immunomodulants-enriched ONS in combination with nutritional counseling in reducing serious AEs rate in patients with advanced GI cancers undergoing systemic treatments.
详细描述
The aim of the present project is to evaluate, with a randomized open-label study, the effect of providing nutritional counselling combined with a high-protein and high-calorie ONS enriched with immunonutrients named LH BLU in reducing serious AEs rate in patients with advanced GI cancers undergoing first-line treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Will to participate by providing written IC.
- •Male or female aged 18 years or older.
- •A confirmed histological or radiological (in case of hepatocellular carcinoma) diagnosis of advanced GI cancer.
- •Undergoing first-line systemic treatment for advanced disease as determined by the investigators, following good clinical practice and guidelines.
- •Availability to take ONS.
- •Patient's willingness to undergo blood draws to provide plasma and blood samples for analysis according to study objectives.
- •An ECOG PS of 2 or less.
- •Investigator's assessment of life expectancy ≥ 3 months.
排除标准
- •Are under 18 years of age.
- •Inability to sign an IC.
- •Inability to follow the procedures of the study, e.g. due to language barrier, major psychological disorders, dementia, etc.;
- •Indication to ongoing artificial nutrition support (totally compromised spontaneous food-intake) and incapacity or unavailability to consume ONS;
- •Pregnancy or lactation.
研究组 & 干预措施
LH BLU
Patients of interventional group will receive the immunomodulant LH BLU and nutritional counseling consisting of a personalized dietary prescription (including sample meal plans and recipe suggestions) tailored on personal eating patterns and food preferences in order to achieve estimated protein-calorie requirements and taking into account chewing and swallowing abilities.
干预措施: LH BLU (Dietary Supplement)
ONS
Patients of interventional group will receive nutritional counseling consisting of a personalized dietary prescription (including sample meal plans and recipe suggestions) tailored on personal eating patterns and food preferences in order to achieve estimated protein-calorie requirements and taking into account chewing and swallowing abilities.
干预措施: ONS (Dietary Supplement)
结局指标
主要结局
Absolute risk difference between study arms in the incidence of grade ≥ 3 AEs.
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.
Absolute risk difference between study arms in the incidence of grade ≥ 3 AEs, as defined by the Common Terminology Criteria for Adverse Events, version 5.0.
次要结局
未报告次要终点