用于提高转移性非小细胞肺癌患者免疫疗法疗效的免疫营养 (MURAL)
多中心、随机、开放标签、平行组试验，以评估免疫营养在提高接受系统营养咨询的转移性非小细胞肺癌患者免疫疗法疗效方面的作用
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
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Riccardo Caccialanza, MD
- 电话号码：0039 0382501615
- 邮箱：r.caccialanza@smatteo.pv.it
研究联系人备份
- 姓名：Alessandra Ferrari, PharmD
- 电话号码：0039 0382503689
- 邮箱：alessandra.ferrari@smatteo.pv.it
学习地点
-
-
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Pavia、意大利
- 招聘中
- Fondazione IRCCS Policlinico San Matteo
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接触：
- Riccardo Caccialanza, MD
- 电话号码：+390382501615
- 邮箱：r.caccialanza@smatteo.pv.it
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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 |
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 |
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有源比较器：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. |
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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Progression-Free Survival (PFS)
大体时间：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. |
12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall survival
大体时间：24 months
|
Overall survival |
24 months
|
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Duration of response
大体时间：24 months
|
Time to progression |
24 months
|
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Treatment-related moderate-severe adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE v5.0]
大体时间：4 months
|
Difference in the incidence of grade >=3 toxicity, according to CTCAE v5.0 |
4 months
|
|
Skeletal muscle mass
大体时间：12 months
|
Change in skeletal muscle mass during the study evaluated with bioimpedance vectorial analysis and computed tomography scans |
12 months
|
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Fatigue
大体时间：12 months
|
Change in fatigue during the study as assessed by the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) questionnaire |
12 months
|
|
Self-perceived quality of life
大体时间：12 months
|
Change in quality of life during the study as assessed by validated questionnaires |
12 months
|
|
Self-reported physical activity level
大体时间：12 months
|
Change in self-reported physical activity level as assessed by the Godin's Shepard Leisure Time Exercise Questionnaire |
12 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Serum levels of immunologic markers
大体时间：12 months
|
Change in levels of soluble effectors and immuno-regulatory cells during the study by cytofluorimetry and validated biochemical assays |
12 months
|
合作者和调查者
合作者
调查人员
- 首席研究员：Riccardo Caccialanza, MD、Fondazione IRCCS Policlinico San Matteo
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 0020364/22
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Depending on a specific research question and according to a study protocol to be approved by the Ethics Committee
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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