Atorvastatin in Preventing Nasopharyngeal Carcinoma Patients Receiving Radiotherapy From Carotid Stenosis
Information source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nasopharyngeal Carcinoma; Radiation Therapy Complication
Intervention: Atorvastatin (Drug); Placebo (Other)
Phase: Phase 2
Status: Recruiting
Sponsored by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Official(s) and/or principal investigator(s): Ying Peng, Ph.D, Principal Investigator, Affiliation: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Overall contact: Ying Peng, Ph.D, Phone: +8613380051581, Email: 2353352460@qq.com
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.
Clinical Details
Official title: Atorvastatin in Preventing Nasopharyngeal Carcinoma Patients Receiving Radiotherapy From Carotid Stenosis: A Multicenter, Double-blind, Placebo-Controlled, Randomized Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: Change from baseline in maximal of IMT of bilateral carotid arteries
Secondary outcome: Incidence of sever carotid stenosisIncidence of cardiovascular events
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
Minimum age: 40 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Ying Peng, Ph.D, Phone: +8613380051581, Email: 2353352460@qq.com
Dongguan People's Hospital, Dongguan, Guangdong 523059, China; Recruiting Weimin Xiao, Ph.D Weimin Xiao, Ph.D, Principal Investigator
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong 510120, China; Recruiting Ying Peng, Ph.D, Phone: +8613380051581, Email: 2353352460@qq.com Yamei Tang, Ph.D, Phone: +8613556001992, Email: yameitang@hotmail.com Ying Peng, Ph.D, Principal Investigator
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong 510060, China; Recruiting Ying Sun, Ph.D, Phone: +8613688856258, Email: sunying2@mail.sysu.edu.cn Ying Sun, Ph.D, Principal Investigator
Zengcheng People's Hospital, Zengcheng, Guangdong 511300, China; Recruiting Qingyu Shen, Ph.D, Phone: +8613609710406, Email: super-shen@126.com Qingyu Shen, Ph.D, Principal Investigator
The Affiliated Hospital of Guangdong Medical College, Zhanjiang, Guangdong 524001, China; Recruiting Bin Zhao, Ph.D, Email: zhaobime@163.net Bin Zhao, Ph.D, Principal Investigator
The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi 530021, China; Recruiting Chao Qin, Ph.D, Email: mdqc6639@126.com Chao Qin, Ph.D, Principal Investigator
Additional Information
Starting date: December 2013
Last updated: February 7, 2014
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