此页面是自动翻译的，不保证翻译的准确性。请参阅英文版对于源文本。

Atorvastatin in Preventing Nasopharyngeal Carcinoma Patients Receiving Radiotherapy From Carotid Stenosis

2017年12月1日更新者：Yamei Tang、Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Atorvastatin in Preventing Nasopharyngeal Carcinoma Patients Receiving Radiotherapy From Carotid Stenosis: A Multicenter, Double-blind, Placebo-Controlled, Randomized Trial

Patients with head and neck cancer who underwent irradiation have a higher risk of developing severe carotid stenosis, and eventually develop to transient ischemic attack or stroke. However, it's still not clear whether early intervene in vascular risk factors is benefit for patients after radiotherapy.

Our study aimed to evaluate the feasibility and safety of atorvastatin for preventing NPC patients after radiotherapy from severe carotid stenosis. In a randomized, double-blind, placebo-controlled trial, about 324 nasopharyngeal carcinoma (NPC) patients will be enrolled from six centers in Guangdong Province and randomized 1:1 to atorvastatin group or placebo group.

研究概览

地位

暂停

条件

干预/治疗

详细说明

It is a randomized, double-blind, placebo-controlled trial, about 324 nasopharyngeal carcinoma (NPC) patients will be enrolled from six centers in Guangdong Province and randomized 1:1 to atorvastatin group (20mg per night, totally 2 years) or placebo group. All Patients will be followed up for 2 years. Ultrasound and Transcranial Color Doppler (TCD) will be used to evaluate the changes of intima-media thickness (IMT) and occurrence of plaque formation of carotid arteries. Safety will be monitored every 6 months.

研究类型

介入性

注册 (预期的)

324

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

中国
- Guangdong
  - Dongguan、Guangdong、中国、523059
    - Dongguan People's Hospital
  - Guangzhou、Guangdong、中国、510060
    - Sun Yat-sen University Cancer Center
  - Guangzhou、Guangdong、中国、510120
    - Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
  - Zengcheng、Guangdong、中国、511300
    - Zengcheng People's Hospital
  - Zhanjiang、Guangdong、中国、524001
    - The Affiliated Hospital of Guangdong Medical College
- Guangxi
  - Nanning、Guangxi、中国、530021
    - The First Affiliated Hospital of Guangxi Medical University

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

40年至 65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:

Patients must have received radiation therapy for histologically confirmed nasopharyngeal carcinoma.
Prior irradiation <3 years prior to study entry.
Male or fertile women who are willing to take contraception during the trial.
Age 40-65 years old.
Carotid stenosis < 50%.
LDL-C between 100mg/dL（2.5mmol/L）and 190mg/dL（4.9mmol/L）.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

History of bleeding related to tumor or radiotherapy during or after radiation.
Evidence of tumor invasion to major vessels(for example the carotid artery).
Severe complications, such as history of stroke, myocardial infarction, liver diseases, thyroid dysfunction, inadequately controlled hypertension and epilepsy.
Familial hypercholesterolemia.
Taking lipid-lowing drugs.
Aspartate aminotransferase(AST) or alanine aminotransferase(ALT) >upper limits of normal (ULN), creatinine >ULN.
Allergic history of atorvastatin.

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：随机化
介入模型：并行分配
屏蔽：双倍的

手臂数量

武器和干预

参与者组/臂	干预/治疗
有源比较器：Atorvastatin Patients will take atorvastatin 20mg per night, totally 2 years.	药品：Atorvastatin Patients in this group will take 20mg per night. 其他名称：立普妥 Atorvastatin Calcium Tablets
安慰剂比较：Placebo Patients will take placebo once per night for 2 years. The appearance and dosage of placebo will be the same as atorvastatin.	其他：安慰剂

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 from baseline in maximal of IMT of bilateral carotid arteries 大体时间：At baseline and 2 years	Patients will take Ultrasound and Transcranial Color Doppler every 6 months to measure the thickness of intima-media thickness (IMT) and occurrence of plaque formation of carotid arteries. We will compare the maximal IMT of bilateral carotid arteries at 2 years from baseline.	At baseline and 2 years

次要结果测量

结果测量	措施说明	大体时间
Incidence of sever carotid stenosis 大体时间：At 2 years	Patients will be followed up for 2 years. We defined sever carotid stenosis as stenosis>50% by using ultrasound and TCD.	At 2 years
Incidence of cardiovascular events 大体时间：At 2 years	Patients will be followed up for 2 years and cardiovascular events such as stroke, transient ischemic attack (TIA) will be recorded.	At 2 years

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。

赞助

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

调查人员

首席研究员：Ying Peng, Ph.D、Sun Yat-sen Memorial Hospital,Sun Yat-sen University

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)

2017年1月1日

初级完成 (预期的)

2023年12月1日

研究完成 (预期的)

2024年1月1日

研究注册日期

首次提交

2013年12月11日

首先提交符合 QC 标准的

2013年12月20日

首次发布 (估计)

2013年12月27日

研究记录更新

最后更新发布 (实际的)

2017年12月4日

上次提交的符合 QC 标准的更新

2017年12月1日

最后验证

2017年12月1日

Atorvastatin in Preventing Nasopharyngeal Carcinoma Patients Receiving Radiotherapy From Carotid Stenosis