Clinical trial NCT02022293: Atorvastatin in Preventing Nasopharyngeal Carcinoma Patients Receiving Radiotherapy From Carotid Stenosis
Official title: Atorvastatin in Preventing Nasopharyngeal Carcinoma Patients Receiving Radiotherapy From Carotid Stenosis: A Multicenter, Double-blind, Placebo-Controlled, Randomized Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Radiation Therapy Complication
Keywords: Nasopharyngeal Carcinoma
Radiotherapy
Carotid Stenosis
Atorvastatin
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2013-12-27
Enrollment: 324
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in maximal of IMT of bilateral carotid arteries
timeFrame: At baseline and 2 years
Secondary outcomes:
measure: Incidence of sever carotid stenosis
timeFrame: At 2 years
measure: Incidence of cardiovascular events
timeFrame: At 2 years
Other outcomes:
Locations:
city: Dongguan
country: China
facility: Dongguan People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
state: Guangdong
city: Zengcheng
country: China
facility: Zengcheng People's Hospital
state: Guangdong
city: Zhanjiang
country: China
facility: The Affiliated Hospital of Guangdong Medical College
state: Guangdong
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Ying Peng, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: