Radiation-associated Carotid Artery Disease in Patients With Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03568032
• Other study ID #: NPC-CAROTID-01
• Status: Not yet recruiting
• Start date: July 1, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: June 2018
• Source: Fudan University
• Contact: Xiaomin Ou, MD
• Phone: +86 13816287320
• Email: doctorou1012[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 248
• Est. completion date: June 30, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carotid Artery Diseases
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

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.
• Detection and measurement of carotid plaques
Detection and measurement of plaques within internal carotid artery and common carotid artery by ultrasound
• Carotid Color Flow Duplex Testing
Velocity measurement of carotid artery to determine carotid stenosis
• 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.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.