Atorvastatin in Preventing Nasopharyngeal Carcinoma Patients Receiving Radiotherapy From Carotid Stenosis

Phase 2SuspendedNCT02022293

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University324 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

324

Conditions

Nasopharyngeal Carcinoma Radiation Therapy Complication

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (6)

Dongguan People's Hospital

Dongguan, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Zengcheng People's Hospital

Licheng, Guangdong, China

The Affiliated Hospital of Guangdong Medical College

Zhanjiang, Guangdong, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Outcomes

Primary Outcomes

Change from baseline in maximal of IMT of bilateral carotid arteries

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.

Time frame: At baseline and 2 years

Secondary Outcomes

Incidence of sever carotid stenosis

Patients will be followed up for 2 years. We defined sever carotid stenosis as stenosis\>50% by using ultrasound and TCD.

Time frame: At 2 years

Incidence of cardiovascular events

Patients will be followed up for 2 years and cardiovascular events such as stroke, transient ischemic attack (TIA) will be recorded.