Nutritional Status in Children Treated With Advanced Nutrition Therapy (NUTRIENT)
Background: There are few studies about nutrition to children and adolescents with cancer, and in particular during stem cell transplantation (SCT). Studies from other countries suggest that malnutrition is common on admission; the situation decline during treatment and may persist for a long time.
Aim: This project aims to improve the nutritional therapy to children being treated for cancer and children undergoing stem cell transplantation
研究概览
详细说明
Design, methodology and selection: The study consist of two parts: A retrospective study (registry study) of malnutrition among all children with cancer, admitted during a two year period, and a clinical trial to evaluate the effect of a standardized nutrition protocol for children undergoing SCT. Nutritional status is assessed before, during and one year after treatment with SCT.
The subjects are 140 children and adolescents (2-17 years) being treated for cancer and a subgroup of 25 patients treated with SCT at Oslo University. The results will be compared with a reference group of 25 patients treated with home parenteral nutrition as well as 50 healthy reference persons in the same age group.
The methods used for measurement of nutritional status are: Body composition, bone density, blood tests, diet record, activity detection and measurement of quality of life. The measurements are done on three occasions for patients with cancer and stem cell transplantation, and on one occasion with a reference. Information on demographics and medical care will be taken from journal. Growth data will be collected from health centres when needed. Parents' experiences of children's feeding problems will also be examined.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Oslo、挪威
- Oslo University Hospital
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Oslo、挪威、0316
- University of Oslo
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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:
- All patients will be recruited from Oslo University Hospital. Inclusion criteria are age 2 -17 years of age. The SCT and HPN group will include children who have not previously undergone transplantation, who do not have a pacemaker or other implants that prevent the measurement of muscle mass. Participants in the reference groups will be of the same age group, without congenital syndromes or previous cancers.
Exclusion Criteria:
- Exclusion criteria are patients who reject bone marrow
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：非随机化
- 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 |
|---|---|
|
实验性的：Stem cell transplantation (SCT)
Children undergoing stem cell transplantation (SCT)
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Body composition and nutrient status
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无干预：Home parenteral nutrition (HPN)
Children receiving home parenteral nutrition
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无干预：Healthy reference group
Healthy children
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Body composition meassured with Lunar Dxa
大体时间：After one year
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After one year
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
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Blood vitamins and minerals
大体时间：After one year
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After one year
|
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Dietary intake
大体时间：After one year
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After one year
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Physical activity
大体时间：After one year
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After one year
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Health related Quality of life
大体时间：After one year
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After one year
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
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
关键字
其他研究编号
- AEV2017/1
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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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