Nasopharyngeal Carcinoma, Radiation Therapy Complication
Conditions
Keywords
Nasopharyngeal Carcinoma, Radiotherapy, Carotid Stenosis, Atorvastatin
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.
Interventions
DRUGAtorvastatin
Patients in this group will take 20mg per night.
OTHERPlacebo
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed