Multicentre, Randomised, Open-label, Parallel-group Trial to Evaluate Immunonutrition in Improving Efficacy of Immunotherapy in Patients With Metastatic Non-small Cell Lung Cancer, Undergoing Systematic Nutritional Counseling
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
The present study was designed to evaluate the efficacy of the early systematic provision of oral nutritional supplements enriched in immunonutrients in non-small lung cancer patients undergoing immunotherapy and receiving nutritional counseling
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
- 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
- •Confirmed histological diagnosis of metastatic non-small cell lung cancer (both squamous and non-squamous histology);
- •First-line treatment with immunotherapy (alone or in combination with chemotherapy) for metastatic disease by investigators' choice within the framework of good clinical practice and in agreement with current guidelines;
- •Will to participate by providing written informed consent;
- •Availability to administer oral supplements and immunotherapy with or without chemotherapy;
- •Eastern Cooperative Oncology Group Performance Status ≤ 2;
- •Life expectancy ≥ 6 months.
排除标准
- •Age < 18 years;
- •Inability to sign an informed consent;
- •Indication to or ongoing artificial nutrition support (totally compromised spontaneous food-intake) and incapacity or unavailability to consume oral nutritional supplements
研究组 & 干预措施
Immunonutrition
In addition to nutritional counseling, patients will receive two servings of an oral high-calorie-high-protein nutritional liquid supplement enriched in immunonutrients (Oral Impact®). The intervention will start approximately two weeks before anticancer treatment initiation and will continue up to first disease re-assessment (12-14 weeks) and prolonged according to patient's needs
干预措施: Immunonutrition (Dietary Supplement)
Control dietary intervention
Patients will receive nutritional counseling as standard of care. Nutritional counseling may comprise the use of oral nutritional supplements (ONS), which are usually prescribed when patients are unable to maintain satisfactory spontaneous food intake (less than 50% of the requirement for more than one week or only 50-75% of the requirement for more than two weeks). Therefore, in this arm the use of isonitrogenous standard blend ONS will be considered according to the regular assessment of food intake.
干预措施: Control dietary intervention (Other)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: 12 months
A progression-free survival rate at 12 months will be calculated, with patients categorized in a dichotomous manner as alive and progression-free or in progression or dead at 12 months.
次要结局
- Overall survival(24 months)
- Duration of response(24 months)
- Skeletal muscle mass(12 months)
- Treatment-related moderate-severe adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE v5.0](4 months)
- Fatigue(12 months)
- Self-perceived quality of life(12 months)
- Self-reported physical activity level(12 months)
研究者
Riccardo Caccialanza
Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia