Radiation-associated Carotid Artery Disease in Patients With Nasopharyngeal Carcinoma

June 13, 2018 updated by: Xiayun He, MD, Fudan University

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

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

248

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: This is a cross-sectional study. So the time frame is within one week of a patient-visit to the clinics.
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
Time Frame: This is a cross-sectional study. So the time frame is within one week of a patient-visit to the clinics.
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
Time Frame: This is a cross-sectional study. So the time frame is within one week of a patient-visit to the clinics.
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)
Time Frame: This is a cross-sectional study. So the time frame is within one week of a patient-visit to the clinics.
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

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Xiayun He, MD, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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