Radiation-associated Carotid Artery Disease in Patients With Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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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).

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

Conditions
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Nasopharyngeal Carcinoma, Carotid Artery Diseases

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| the post-radiation group<br>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<br>* 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.<br>Diagnostic Test: Detection and measurement of carotid plaques<br>* Detection and measurement of plaques within internal carotid artery and common carotid artery by ultrasound<br>Diagnostic Test: Carotid Color Flow Duplex Testing<br>* Velocity measurement of carotid artery to determine carotid stenosis<br>Diagnostic Test: Montreal Cognitive Assessment<br>* Cognitive assessment<br>Other: Medical history of cardiovascular risk factors and cardiovascular diseases<br>* Cardiovascular risk factors include smoking, alcohol consumption, hypertension, diabetes mellitus, hypercholesterolemia, obesity. Cardiovascular diseases include ischemic stroke, ischemic coronary heart disease, TIA, etc.<br>|
| the pre-radiation group<br>untreated patients diagnosed as non-metastatic nasopharyngeal carcinoma | Diagnostic Test: Measurement of intima media thickness of carotid artery<br>* 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.<br>Diagnostic Test: Detection and measurement of carotid plaques<br>* Detection and measurement of plaques within internal carotid artery and common carotid artery by ultrasound<br>Diagnostic Test: Carotid Color Flow Duplex Testing<br>* Velocity measurement of carotid artery to determine carotid stenosis<br>Diagnostic Test: Montreal Cognitive Assessment<br>* Cognitive assessment<br>Other: Medical history of cardiovascular risk factors and cardiovascular diseases<br>* Cardiovascular risk factors include smoking, alcohol consumption, hypertension, diabetes mellitus, hypercholesterolemia, obesity. Cardiovascular diseases include ischemic stroke, ischemic coronary heart disease, TIA, etc.<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intima media thickness