Effectiveness of Nutritional Interventions for Cancer Patients Undergoing Chemotherapy
2026年9月16日 更新者：Hanoi Medical University
This study aims to estimate the effects of nutritional interventions on the improvement of nutritional status and quality of life (QoL) among gastrointestinal patients in Vietnam
研究概览
详细说明
A quasi-experiment with intervention and control groups for pre- and post-intervention assessment was carried out at the Department of Oncology and Palliative Care - Medical University Hospital from 2016 to 2019.
60 gastrointestinal cancer patients were recruited in each group.
At stage 1, we selected patients of the intervention group who met the inclusion criteria to receive nutritional counseling and diet at the hospital.
At stage 2, we chose patients who were eligible but did not accept the nutritional counseling and diet at the hospital.
Participants in both groups were paired together according to the following criteria: 1) Age group: <40 years old, 40-65 years old and >65 years old; 2) Gender: Male and female; 3) Types of cancer: stomach cancer and colon cancer; 4) Disease stages: stage 1-2 and stage 3-4.
研究类型
介入性
注册 (实际的)
120
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
描述
Inclusion Criteria:
- aged 18 years old or above
- diagnosed with stomach or colon cancer;
- at the initial of receiving chemotherapy treatment;
- indicated for oral feeding;
- not having co-morbidities of chronic diseases such as kidney failure, heart failure, liver failure, diabetes;
- having ability to communicate with data collectors and both attending doctors and agreeing to involve in the study
Exclusion Criteria:
- treated by other methods such as radiation, endocrine, immunity;
- undergoing terminal palliative care;
- having contraindications to oral feeding/enteral nutrition
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Intervention group
Regarding the intervention group, patients were treated with the intervention regimen, which consisted of:
|
Each patient was assigned a specific menu which were prepared by research members during the time of staying at the hospital.
Before discharge, patients were instructed on preparing their diets at home with the recommended amount of energy and protein and given formula milk within two months
|
|
无干预：Control group
Patients had diets based on their demands
|
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 |
|---|---|---|
|
Change of nutritional status after 8 weeks
大体时间：Baseline and 8 weeks
|
The Scored Patient-Generated Subjective Global Assessment (PG-SGA) was used as the preeminent interdisciplinary patient assessment among patients with oncology.
This tool includes (1) four patient-generated historical components (Weight History, Food Intake, Symptoms, Activities and Function); (2) the professional part (Diagnosis, Metabolic stress, and Physical Exam); (3) the Global Assessment (A = well-nourished, B = moderately malnourished, C = severely malnourished); (4) the total score, and nutritional triage recommendations.
Changes in anthropometric indicators were also reported (weight, MUAC, muscle mass)
|
Baseline and 8 weeks
|
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Change of quality of life after 8 weeks: European Organisation for Research and Treatment of Cancer (EORTC) version 3.0
大体时间：Baseline and 8 weeks
|
We utilized the European Organisation for Research and Treatment of Cancer (EORTC) version 3.0, which is an integrated and modular approach to holistically evaluate the QoL of patients with cancer.all
dimensions of the tool will range from 0 to 100, in which a higher score presents a better level of functioning/the global health status or a worse level of symptoms.
|
Baseline and 8 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年1月15日
初级完成 (实际的)
2019年6月1日
研究完成 (实际的)
2019年12月15日
研究注册日期
首次提交
2020年8月14日
首先提交符合 QC 标准的
2020年8月17日
首次发布 (实际的)
2020年8月18日
研究记录更新
最后更新发布 (实际的)
2026年9月18日
上次提交的符合 QC 标准的更新
2026年9月16日
最后验证
2020年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.