DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 stenosis

Incidence 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017