Atorvastatin in Preventing Nasopharyngeal Carcinoma Patients Receiving Radiotherapy From Carotid Stenosis

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Atorvastatin in Preventing Nasopharyngeal Carcinoma Patients Receiving Radiotherapy From Carotid Stenosis: A Multicenter, Double-blind, Placebo-Controlled, Randomized Trial

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02022293
• Other study ID #: 2013018
• Secondary ID: SYSN003
• Status: Suspended
• Phase: Phase 2
• First received: December 11, 2013
• Last updated: December 1, 2017
• Start date: January 2017
• Est. completion date: January 2024

Study information

• Verified date: December 2017
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 324
• Est. completion date: January 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carotid Stenosis
• Constriction, Pathologic
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms
• Radiation Therapy Complication

Intervention

Drug:
• Atorvastatin
Patients in this group will take 20mg per night.

Other:
• Placebo

Locations

Country	Name	City	State
China	Dongguan People's Hospital	Dongguan	Guangdong
China	Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	Zengcheng People's Hospital	Zengcheng	Guangdong
China	The Affiliated Hospital of Guangdong Medical College	Zhanjiang	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At baseline and 2 years
Secondary	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.	At 2 years
Secondary	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.	At 2 years