Radiation-associated Carotid Artery Disease in Patients With Nasopharyngeal Carcinoma

• Conditions: Nasopharyngeal Carcinoma; Carotid Artery Diseases
• Interventions: 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

• Registration Number: NCT03568032
• Lead Sponsor: Fudan University

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-03-29
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-13
• Last Update Submitted: 2018-06-13
• Study First Posted: 2018-06-26
• Last Update Posted: 2018-06-26
• Study Start: 2018-07-01
• Primary Completion: 2019-05-01
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 248

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
the post-radiation group	Detection and measurement of carotid plaques	patients diagnosed as non-metastatic nasopharyngeal carcinoma who received definitive IMRT more than 3 years ago
the pre-radiation group	Measurement of intima media thickness of carotid artery	untreated patients diagnosed as non-metastatic nasopharyngeal carcinoma
the pre-radiation group	Carotid Color Flow Duplex Testing	untreated patients diagnosed as non-metastatic nasopharyngeal carcinoma
the pre-radiation group	Medical history of cardiovascular risk factors and cardiovascular diseases	untreated patients diagnosed as non-metastatic nasopharyngeal carcinoma
the post-radiation group	Medical history of cardiovascular risk factors and cardiovascular diseases	patients diagnosed as non-metastatic nasopharyngeal carcinoma who received definitive IMRT more than 3 years ago
the post-radiation group	Carotid Color Flow Duplex Testing	patients diagnosed as non-metastatic nasopharyngeal carcinoma who received definitive IMRT more than 3 years ago
the pre-radiation group	Detection and measurement of carotid plaques	untreated patients diagnosed as non-metastatic nasopharyngeal carcinoma
the post-radiation group	Measurement of intima media thickness of carotid artery	patients diagnosed as non-metastatic nasopharyngeal carcinoma who received definitive IMRT more than 3 years ago
the post-radiation group	Montreal Cognitive Assessment	patients diagnosed as non-metastatic nasopharyngeal carcinoma who received definitive IMRT more than 3 years ago
the pre-radiation group	Montreal Cognitive Assessment	untreated patients diagnosed as non-metastatic nasopharyngeal carcinoma

Primary Outcome Measures

Name	Time	Method
intima media thickness of carotid artery	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

Secondary Outcome Measures

Name	Time	Method
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 plaques	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.
the incidence of carotid stenosis	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%.

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China