Atorvastatin in Preventing Nasopharyngeal Carcinoma Patients Receiving Radiotherapy From Carotid Stenosis
NCT ID: NCT02022293
Last Updated: 2017-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE2
324 participants
INTERVENTIONAL
2017-01-31
2024-01-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Atorvastatin
Patients will take atorvastatin 20mg per night, totally 2 years.
Atorvastatin
Patients in this group will take 20mg per night.
Placebo
Patients will take placebo once per night for 2 years. The appearance and dosage of placebo will be the same as atorvastatin.
Placebo
Interventions
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Atorvastatin
Patients in this group will take 20mg per night.
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
65 Years
ALL
No
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
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Yamei Tang
Professer
Principal Investigators
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Ying Peng, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Locations
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Dongguan People's Hospital
Dongguan, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Zengcheng People's Hospital
Licheng, Guangdong, China
The Affiliated Hospital of Guangdong Medical College
Zhanjiang, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Countries
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Other Identifiers
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SYSN003
Identifier Type: -
Identifier Source: secondary_id
2013018
Identifier Type: -
Identifier Source: org_study_id