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Radiation-associated Carotid Artery Disease in Patients With Nasopharyngeal Carcinoma

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ClinicalTrials.gov Identifier: NCT03568032
Recruitment Status : Not yet recruiting
First Posted : June 25, 2018
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Xiayun He, MD, 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).


Condition or disease Intervention/treatment
Nasopharyngeal Carcinoma Carotid Artery Diseases 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

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Study Type : Observational
Estimated Enrollment : 248 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Clinical Study of Radiation-associated Carotid Artery Disease in Patients With Nasopharyngeal Carcinoma Treated by IMRT
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Group/Cohort 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.




Primary Outcome Measures :
  1. intima media thickness of carotid artery [ Time Frame: 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 :
  1. the incidence of carotid stenosis [ Time Frame: 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%.

  2. the number of carotid plaques [ Time Frame: 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.

  3. total number of Montreal Cognitive Score (range: 0-30) [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568032


Contacts
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Contact: Xiaomin Ou, MD +86 13816287320 doctorou1012@163.com

Locations
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China, Shanghai
Fudan University Shanghai Cancer Center Not yet recruiting
Shanghai, Shanghai, China, 200032
Contact: Xiayun He, MD    +86-18017312167    hexiayun1962@126.com   
Contact: Xiaomin Ou, MD    +86-13816287320    doctorou1012@163.com   
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Xiayun He, MD Fudan University

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Responsible Party: Xiayun He, MD, Principal Investigator, Clinical Professor, Fudan University
ClinicalTrials.gov Identifier: NCT03568032     History of Changes
Other Study ID Numbers: NPC-CAROTID-01
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xiayun He, MD, Fudan University:
intima media thickness

Additional relevant MeSH terms:
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Nasopharyngeal 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
Carcinoma
Carotid Artery Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases