Radiation-associated Carotid Artery Disease in Patients With Nasopharyngeal Carcinoma

NCT03568032 | Unknown DMC

• 1 other identifier: NPC-CAROTID-01
• Study Type: observational
• Target: 248
• Locations: 1 country
• Sites: 1

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).

Conditions

Nasopharyngeal Carcinoma; Carotid Artery Diseases

Keywords

intima media thickness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

• 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.

• 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.

Study Arms (2)

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; 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

the pre-radiation group

untreated patients diagnosed as non-metastatic nasopharyngeal carcinoma

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

Interventions

Measurement of intima media thickness of carotid artery DIAGNOSTIC_TEST

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.

the post-radiation group; the pre-radiation group

Detection and measurement of carotid plaques DIAGNOSTIC_TEST

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

the post-radiation group; the pre-radiation group

Carotid Color Flow Duplex Testing DIAGNOSTIC_TEST

Velocity measurement of carotid artery to determine carotid stenosis

the post-radiation group; the pre-radiation group

Montreal Cognitive Assessment DIAGNOSTIC_TEST

Cognitive assessment

the post-radiation group; the pre-radiation group

Medical history of cardiovascular risk factors and cardiovascular diseases OTHER

Cardiovascular risk factors include smoking, alcohol consumption, hypertension, diabetes mellitus, hypercholesterolemia, obesity. Cardiovascular diseases include ischemic stroke, ischemic coronary heart disease, TIA, etc.

the post-radiation group; the pre-radiation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is selected from new patients or post-radiation patients who come to the clinics of radiation oncology.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xiayun He, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaomin Ou, MD

CONTACT

+86 13816287320; doctorou1012@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: June 26, 2018
• Study Start: July 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: June 30, 2019
• Last Updated: June 26, 2018

Record last verified: 2018-06

Locations

CN (1)