Effect of Oral Supplements on the Nutritional Status of Locally Advanced Nasopharyngeal Carcinoma Patients
2018年3月16日 更新者：Guopei Zhu、Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
A Randomized Phase II Trial to Assess the Effect of Oral Supplements on the Nutritional Status of Locally Advanced Nasopharyngeal Carcinoma Patients During Concurrent Chemotherapy
Malnutrition is very common in locally advanced nasopharyngeal carcinoma(NPC) patients undergoing current chemoradiotherapy (CRT) due to dysphagia, mucositis, nausea and other treatment-related problems.
Malnutrition is associated with lower physical functioning, lower immune status, more severe (grade III/IV) late RT-induced toxicities, treatment interruption of chemo(radio)therapy, lower chemotherapy response rates, hospital readmission, impaired quality of life (QoL), and increased mortality.
Although the international guidelines recommend early nutritional support in the presence of nutritional risk, the best type of nutritional intervention is still unclear.
Individualized dietary counseling showed beneficial effects in nutritional intake, nutritional status and QoL in head and neck cancer patients undergoing RT or CRT-treatment; oral nutritional supplements (ONS) was most acceptable in Chinese NPC patients.
Previous nutritional intervention trials in head-neck cancer patients have been conducted on small samples and did not clarify the role of oral nutritional supplements (ONS).
Accordingly, although current guidelines recommend as grade A the use of ONS associated with dietary counseling for head-neck cancer patients undergoing RT, the efficacy of this nutritional intervention still needs to be evaluated in adequately sized and randomized clinical trials for Chinese NPC patients.
研究概览
研究类型
介入性
注册 (预期的)
60
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Shanghai
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Shanghai、Shanghai、中国、200011
- Shanghai Ninth People's Hospital
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-
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 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Newly diagnosed、pathologically proven nasopharyngeal carcinoma（Stage III/IV）
- Concurrent radiation and chemotherapy(platinum )
- Karnofsky score over 60
- No evidence of metastatic disease
- No significant cardiac, chest, gastrointestinal or renal morbidities
Exclusion Criteria:
- age <18 years
- ongoing artificial nutrition
- refusal
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：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 |
|---|---|
|
实验性的：ONS group
Individualized dietary counseling+ONS(Healing elements)during CRT Interventions: (Healing elements)
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ONS group will receive Healing Elements ONS everyday during CRT
|
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无干预：control group
Individualized dietary counseling during CRT
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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 weight(kg)change during concurrent chemotherapy
大体时间：every week during the course of radiotherapy, up to 6-7 weeks
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every week during the course of radiotherapy, up to 6-7 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Disease-free survival
大体时间：2 years
|
From date of randomization until date of first documented disease progression or death from any cause, assessed up to 2 years.
|
2 years
|
|
Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) during the concurrent treatment
大体时间：every 2 weeks during the course of radiotherapy, up to 6-7 weeks
|
participants will be followed for the duration of hospital stay, an expected average of 6-7 weeks
|
every 2 weeks during the course of radiotherapy, up to 6-7 weeks
|
|
Number of participants with treatment-related adverse events as assessed by CTCAE v3.0
大体时间：every week during the course of radiotherapy, up to 6-7 weeks
|
every week during the course of radiotherapy, up to 6-7 weeks
|
|
|
Body cell mass(kg) change measured by multifrequency segmental bioelectrical impedance analysis
大体时间：every week during the course of radiotherapy, up to 6-7 weeks
|
every week during the course of radiotherapy, up to 6-7 weeks
|
|
|
Fat mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis
大体时间：every week during the course of radiotherapy, up to 6-7 weeks
|
every week during the course of radiotherapy, up to 6-7 weeks
|
|
|
Fat free mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis
大体时间：every week during the course of radiotherapy, up to 6-7 weeks
|
every week during the course of radiotherapy, up to 6-7 weeks
|
|
|
Skeletal muscle mass (kg) change measured by multifrequency segmental bioelectrical impedance analysis
大体时间：every week during the course of radiotherapy, up to 6-7 weeks
|
every week during the course of radiotherapy, up to 6-7 weeks
|
|
|
Phase angle(°) change measured by multifrequency segmental bioelectrical impedance analysis
大体时间：every week during the course of radiotherapy, up to 6-7 weeks
|
every week during the course of radiotherapy, up to 6-7 weeks
|
|
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Serum albumin（g/L) change
大体时间：every 2 weeks during the course of radiotherapy, up to 6-7 weeks
|
every 2 weeks during the course of radiotherapy, up to 6-7 weeks
|
|
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Serum prealbumin（mg/dL) change
大体时间：every 2 weeks during the course of radiotherapy, up to 6-7 weeks
|
every 2 weeks during the course of radiotherapy, up to 6-7 weeks
|
|
|
Serum transferrins（mg/dL）change
大体时间：every 2 weeks during the course of radiotherapy, up to 6-7 weeks
|
every 2 weeks during the course of radiotherapy, up to 6-7 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。
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
2014年6月1日
初级完成 (实际的)
2016年8月1日
研究完成 (实际的)
2018年1月1日
研究注册日期
首次提交
2016年5月3日
首先提交符合 QC 标准的
2016年5月15日
首次发布 (估计)
2016年5月18日
研究记录更新
最后更新发布 (实际的)
2018年3月19日
上次提交的符合 QC 标准的更新
2018年3月16日
最后验证
2018年3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.