Atorvastatin in Preventing Nasopharyngeal Carcinoma Patients Receiving Radiotherapy From Carotid Stenosis

NCT02022293 | Suspended Phase 2 DMC

• 2 other identifiers: 2013018SYSN003
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 6

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.

Conditions

Nasopharyngeal Carcinoma; Radiation Therapy Complication

Keywords

Nasopharyngeal Carcinoma; Radiotherapy; Carotid Stenosis; Atorvastatin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of sever carotid stenosis

  At 2 years

• Incidence of cardiovascular events

  At 2 years

Study Arms (2)

Atorvastatin

ACTIVE COMPARATOR

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

Drug: Atorvastatin

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Atorvastatin DRUG

Patients in this group will take 20mg per night.

Also known as: Atorvastatin Calcium Tablets, Lipitor

Atorvastatin

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (6)

Dongguan People's Hospital

Dongguan, Guangdong, 523059, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510120, China

Location

Zengcheng People's Hospital

Licheng, Guangdong, 511300, China

Location

The Affiliated Hospital of Guangdong Medical College

Zhanjiang, Guangdong, 524001, China

Location

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Carotid Stenosis

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Ying Peng, Ph.D

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professer

Study Record Dates

• First Submitted: December 11, 2013
• First Posted: December 27, 2013
• Study Start: January 1, 2017
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: December 4, 2017

Record last verified: 2017-12

Locations

CN (6)