Skip to content

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03568032
Enrollment
248
Registered
2018-06-26
Start date
2018-07-01
Completion date
2019-06-30
Last updated
2018-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal Carcinoma, Carotid Artery Diseases

Keywords

intima media thickness

Brief summary

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).

Interventions

DIAGNOSTIC_TESTMeasurement 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_TESTDetection and measurement of carotid plaques

Detection and measurement of plaques within internal carotid artery and common carotid artery by ultrasound

DIAGNOSTIC_TESTCarotid Color Flow Duplex Testing

Velocity measurement of carotid artery to determine carotid stenosis

Cognitive assessment

OTHERMedical 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.

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
intima media thickness of carotid arteryThis 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

Secondary

MeasureTime frameDescription
the incidence of carotid stenosisThis 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%.
total number of Montreal Cognitive Score (range: 0-30)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
the number of carotid plaquesThis 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.

Countries

China

Contacts

Primary ContactXiaomin Ou, MD
doctorou1012@163.com+86 13816287320

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026