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Atorvastatin in Preventing Nasopharyngeal Carcinoma Patients Receiving Radiotherapy From Carotid Stenosis

Primary Purpose

Nasopharyngeal Carcinoma, Radiation Therapy Complication

Status
Suspended
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Atorvastatin
Placebo
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal Carcinoma, Radiotherapy, Carotid Stenosis, Atorvastatin

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dongguan People's Hospital
  • Sun Yat-sen University Cancer Center
  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
  • Zengcheng People's Hospital
  • The Affiliated Hospital of Guangdong Medical College
  • The First Affiliated Hospital of Guangxi Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Atorvastatin

Placebo

Arm Description

Patients will take atorvastatin 20mg per night, totally 2 years.

Patients will take placebo once per night for 2 years. The appearance and dosage of placebo will be the same as atorvastatin.

Outcomes

Primary Outcome Measures

Change from baseline in maximal of IMT of bilateral carotid arteries
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 Outcome Measures

Incidence of sever carotid stenosis
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
Patients will be followed up for 2 years and cardiovascular events such as stroke, transient ischemic attack (TIA) will be recorded.

Full Information

First Posted
December 11, 2013
Last Updated
December 1, 2017
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02022293
Brief Title
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

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Suspended
Why Stopped
Enrollment target could not be achieved.
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma, Radiation Therapy Complication
Keywords
Nasopharyngeal Carcinoma, Radiotherapy, Carotid Stenosis, Atorvastatin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
324 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Atorvastatin
Arm Type
Active Comparator
Arm Description
Patients will take atorvastatin 20mg per night, totally 2 years.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will take placebo once per night for 2 years. The appearance and dosage of placebo will be the same as atorvastatin.
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
Atorvastatin Calcium Tablets, Lipitor
Intervention Description
Patients in this group will take 20mg per night.
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change from baseline in maximal of IMT of bilateral carotid arteries
Description
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.
Time Frame
At baseline and 2 years
Secondary Outcome Measure Information:
Title
Incidence of sever carotid stenosis
Description
Patients will be followed up for 2 years. We defined sever carotid stenosis as stenosis>50% by using ultrasound and TCD.
Time Frame
At 2 years
Title
Incidence of cardiovascular events
Description
Patients will be followed up for 2 years and cardiovascular events such as stroke, transient ischemic attack (TIA) will be recorded.
Time Frame
At 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Peng, Ph.D
Organizational Affiliation
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dongguan People's Hospital
City
Dongguan
State/Province
Guangdong
ZIP/Postal Code
523059
Country
China
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Zengcheng People's Hospital
City
Zengcheng
State/Province
Guangdong
ZIP/Postal Code
511300
Country
China
Facility Name
The Affiliated Hospital of Guangdong Medical College
City
Zhanjiang
State/Province
Guangdong
ZIP/Postal Code
524001
Country
China
Facility Name
The First Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China

12. IPD Sharing Statement

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Atorvastatin in Preventing Nasopharyngeal Carcinoma Patients Receiving Radiotherapy From Carotid Stenosis

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