Atorvastatin in Preventing Nasopharyngeal Carcinoma Patients Receiving Radiotherapy From Carotid Stenosis

Phase 2

Suspended

• Conditions: Nasopharyngeal Carcinoma; Radiation Therapy Complication
• Interventions: Other: Placebo; Drug: Atorvastatin

• Registration Number: NCT02022293
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2013-12-11
• Study First Submitted QC: 2013-12-20
• Study First Posted: 2013-12-27
• Study Start: 2017-01
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-01
• Last Update Posted: 2017-12-04
• Primary Completion: 2023-12
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 324

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients will take placebo once per night for 2 years. The appearance and dosage of placebo will be the same as atorvastatin.
Atorvastatin	Atorvastatin	Patients will take atorvastatin 20mg per night, totally 2 years.

Primary Outcome Measures

Name	Time	Method
Change from baseline in maximal of IMT of bilateral carotid arteries	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of sever carotid stenosis	At 2 years	Patients will be followed up for 2 years. We defined sever carotid stenosis as stenosis\>50% by using ultrasound and TCD.
Incidence of cardiovascular events	At 2 years	Patients will be followed up for 2 years and cardiovascular events such as stroke, transient ischemic attack (TIA) will be recorded.

Trial Locations

Locations (6)

Dongguan People's Hospital; 🇨🇳 Dongguan, Guangdong, China

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangxi Medical University; 🇨🇳 Nanning, Guangxi, China

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China

Zengcheng People's Hospital; 🇨🇳 Zengcheng, Guangdong, China

The Affiliated Hospital of Guangdong Medical College; 🇨🇳 Zhanjiang, Guangdong, China