Atorvastatin in Preventing Nasopharyngeal Carcinoma Patients Receiving Radiotherapy From Carotid Stenosis: A Multicenter, Double-blind, Placebo-Controlled, Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 324
- 试验地点
- 6
- 主要终点
- Change from baseline in maximal of IMT of bilateral carotid arteries
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Atorvastatin
Patients will take atorvastatin 20mg per night, totally 2 years.
干预措施: Atorvastatin (Drug)
Placebo
Patients will take placebo once per night for 2 years. The appearance and dosage of placebo will be the same as atorvastatin.
干预措施: Placebo (Other)
结局指标
主要结局
Change from baseline in maximal of IMT of bilateral carotid arteries
时间窗: 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.
次要结局
- Incidence of sever carotid stenosis(At 2 years)
- Incidence of cardiovascular events(At 2 years)
研究者
Yamei Tang
Professer
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University