Radiation-associated Carotid Artery Disease in Patients With Nasopharyngeal Carcinoma

The Clinical Study of Radiation-associated Carotid Artery Disease in Patients With Nasopharyngeal Carcinoma Treated by IMRT

Radiation-associated carotid vasculopathy is a common late sequelae in patients with head and neck cancer, which correlates with the incidence of stroke. Currently, little is known about the incidence of radiation-associated carotid vasculopahty in the context of intensity-modulated radiation therapy (IMRT).

The aim of this study is to determine whether IMRT will increase the incidence of carotid vasculopathy in patients with nasopharyngeal carcinoma (NPC).

Study Overview

• Status: Unknown
• Conditions: Nasopharyngeal Carcinoma; Carotid Artery Diseases
• Intervention / Treatment: Diagnostic test: Measurement of intima media thickness of carotid artery; Diagnostic test: Detection and measurement of carotid plaques; Diagnostic test: Carotid Color Flow Duplex Testing; Diagnostic test: Montreal Cognitive Assessment; Other: Medical history of cardiovascular risk factors and cardiovascular diseases

• Study Type: Observational
• Enrollment (Anticipated): 248

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population is selected from new patients or post-radiation patients who come to the clinics of radiation oncology.

Description

Inclusion Criteria:

• signed inform consent
• age more than 18 years old
• ECOG 0-2
• pathologic diagnosed, non-metastatic NPC
• either untreated or treated by definitive IMRT 3 years ago
• did not receive radiation to the head and neck region prior to the diagnosis of NPC
• if the patient received definitive IMRT 3 years ago because of NPC, he or she did not receive a second course of radiation due to local relapse
• no prior surgery of head and neck

Exclusion Criteria:

• prior history of cardiovascular disease before the diagnosis of NPC
• prior radiation to head and neck before the diagnosis of NPC
• prior surgery of head and neck
• pregnant or lactating women

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
the post-radiation group; patients diagnosed as non-metastatic nasopharyngeal carcinoma who received definitive IMRT more than 3 years ago	Diagnostic test: Measurement of intima media thickness of carotid artery; IMT measurements were performed using ultrasound machine in the pre-radiation and the post-radiation group. IMT was assessed at the common carotid artery (CCA) and the internal carotid artery (ICA) of both the left and right side.; Diagnostic test: Detection and measurement of carotid plaques; Detection and measurement of plaques within internal carotid artery and common carotid artery by ultrasound; Diagnostic test: Carotid Color Flow Duplex Testing; Velocity measurement of carotid artery to determine carotid stenosis; Diagnostic test: Montreal Cognitive Assessment; Cognitive assessment; Other: Medical history of cardiovascular risk factors and cardiovascular diseases; Cardiovascular risk factors include smoking, alcohol consumption, hypertension, diabetes mellitus, hypercholesterolemia, obesity. Cardiovascular diseases include ischemic stroke, ischemic coronary heart disease, TIA, etc.
the pre-radiation group; untreated patients diagnosed as non-metastatic nasopharyngeal carcinoma	Diagnostic test: Measurement of intima media thickness of carotid artery; IMT measurements were performed using ultrasound machine in the pre-radiation and the post-radiation group. IMT was assessed at the common carotid artery (CCA) and the internal carotid artery (ICA) of both the left and right side.; Diagnostic test: Detection and measurement of carotid plaques; Detection and measurement of plaques within internal carotid artery and common carotid artery by ultrasound; Diagnostic test: Carotid Color Flow Duplex Testing; Velocity measurement of carotid artery to determine carotid stenosis; Diagnostic test: Montreal Cognitive Assessment; Cognitive assessment; Other: Medical history of cardiovascular risk factors and cardiovascular diseases; Cardiovascular risk factors include smoking, alcohol consumption, hypertension, diabetes mellitus, hypercholesterolemia, obesity. Cardiovascular diseases include ischemic stroke, ischemic coronary heart disease, TIA, etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intima media thickness of carotid artery	the intima media thickness of common carotid artery, internal carotid artery of the left or right side	This is a cross-sectional study. So the time frame is within one week of a patient-visit to the clinics.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of carotid stenosis	Carotid stenosis is defined as the axial diameter of the carotid lumina decreases more than 50%.	This is a cross-sectional study. So the time frame is within one week of a patient-visit to the clinics.
the number of carotid plaques	Carotid plaque is defined as a focal structure that encroaches into the arterial lumen of at least 0.5 mm or 50% of the surrounding IMT value or demonstrates a thickness >1.5 mm as measured from the media-adventitia interface to the intima- lumen interface.	This is a cross-sectional study. So the time frame is within one week of a patient-visit to the clinics.
total number of Montreal Cognitive Score (range: 0-30)	the higher the number, the better the cognitive function	This is a cross-sectional study. So the time frame is within one week of a patient-visit to the clinics.

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Xiayun He, MD, Fudan University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2018
• Primary Completion (ANTICIPATED): May 1, 2019
• Study Completion (ANTICIPATED): June 30, 2019

Study Registration Dates

• First Submitted: March 29, 2018
• First Submitted That Met QC Criteria: June 13, 2018
• First Posted (ACTUAL): June 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 26, 2018
• Last Update Submitted That Met QC Criteria: June 13, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: intima media thickness
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma; Carotid Artery Diseases
• Other Study ID Numbers: NPC-CAROTID-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No