Radiation-associated Carotid Artery Disease in Patients With Nasopharyngeal Carcinoma
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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%.
- 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.
- 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
Eligibility Criteria
Criteria
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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fudan University Shanghai Cancer Center | Shanghai | Shanghai | China | 200032 |
Sponsors and Collaborators
- Fudan University
Investigators
- Principal Investigator: Xiayun He, MD, Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NPC-CAROTID-01