Atorvastatin in Preventing Nasopharyngeal Carcinoma Patients Receiving Radiotherapy From Carotid Stenosis

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)

Overall Status

Suspended

CT.gov ID

NCT02022293

Collaborator

(none)

324

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nasopharyngeal Carcinoma Radiation Therapy Complication	Drug: Atorvastatin Other: Placebo	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

324 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 1, 2017

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Atorvastatin Patients will take atorvastatin 20mg per night, totally 2 years.	Drug: Atorvastatin Patients in this group will take 20mg per night. Other Names: Atorvastatin Calcium Tablets Lipitor
Placebo Comparator: Placebo Patients will take placebo once per night for 2 years. The appearance and dosage of placebo will be the same as atorvastatin.	Other: Placebo

Arm

Intervention/Treatment

Active Comparator: Atorvastatin

Patients will take atorvastatin 20mg per night, totally 2 years.

Drug: Atorvastatin

Patients in this group will take 20mg per night.

Other Names:

Atorvastatin Calcium Tablets

Lipitor

Placebo Comparator: Placebo

Patients will take placebo once per night for 2 years. The appearance and dosage of placebo will be the same as atorvastatin.

Other: Placebo

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dongguan People's Hospital	Dongguan	Guangdong	China	523059
2	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong	China	510060
3	Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University	Guangzhou	Guangdong	China	510120
4	Zengcheng People's Hospital	Zengcheng	Guangdong	China	511300
5	The Affiliated Hospital of Guangdong Medical College	Zhanjiang	Guangdong	China	524001
6	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi	China	530021