A Prospective Study of Prophylactic Gastrostomy in Head and Neck Cancer Patients Undergoing Chemoradiotherapy
A Prospective Study of Prophylactic Gastrostomy in Head and Neck Cancer Patients Undergoing Chemoradiotherapy in Medical Practice
研究概览
详细说明
Nutritional status is one of the essential factor to determine outcome of chemoradiotherapy in head and neck cancer patients. Almost all these patients develop mucositis during the treatment, which usually leads to treatment interruptions and affects the efficacy of the treatment. Prophylactic gastrostomy has been accepted for these patients with improvement of quality of life. However, there is no prospective study confirming superiority of such treatment.
The investigators enrolled head and neck cancer patients who had the plan of chemoradiotherapy. The patients will be informed about both treatment arms and will decide the arm that they preferred. The treatment interruptions, body weight and nutritional status will be assessed every 2 weeks during treatment period.
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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Bangkok、泰国、10700
- Division of medical oncology, department of medicine Siriraj Hospital
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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:
- pathologically confirmed of head and neck cancer
- plan to have chemoradiotherapy session
- Performance status of 0-2
Exclusion Criteria:
- contraindications for percutaneous gastrostomy, eg coagulopathy, obstructed tumor
- Body mass index less than 16 kg/m2
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 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 |
|---|---|
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无干预：control
nutrition counselling with nasogastric tube insertion in the cases of weight loss more than 10% or severe mucositis developed during chemoradiotherapy
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实验性的：prophylactic percutaneous gastrostomy
prophylactic percutaneous gastrostomy with nutrition counselling
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prophylactic percutaneous gastrostomy with nutrition counselling
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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 |
|---|---|
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treatment interruption due to toxicity
大体时间：during period of chemoradiatherapy, an expected average of 6 weeks
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during period of chemoradiatherapy, an expected average of 6 weeks
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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quality of life
大体时间：during period of chemoradiation, an expected avearage of 6 weeks
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during period of chemoradiation, an expected avearage of 6 weeks
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合作者和调查者
调查人员
- 首席研究员：Suthinee Ithimakin, MD、Faculty of Medicine Siriraj Hospital
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
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 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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