Atorvastatin in Preventing Nasopharyngeal Carcinoma Patients Receiving Radiotherapy From Carotid Stenosis

Sun Yat-sen University

Status and phase

Suspended

Phase 2

Conditions

Radiation Therapy Complication

Nasopharyngeal Carcinoma

Treatments

Other: Placebo

Drug: Atorvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT02022293

2013018

SYSN003

Details and patient eligibility

About

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.

Full 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.

Enrollment

324 estimated patients

Sex

All

Ages

40 to 65 years old

Volunteers

No 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.