Carotid Artery Stenosis and Ischemic Cerebrovascular Events After Radiotherapy in Patients With Head and Neck Cancer

NCT06556979 | Completed DMC

• 1 other identifier: EC 048/2565
• Study Type: observational
• Target: 907
• Locations: 1 country
• Sites: 1

Brief Summary

The study had a cross-sectional design and included patients with HNC involving the oral cavity, pharynx, larynx, nasal cavity, or salivary glands who recieve RT. the investigators obtained information on their clinical and tumor characteristics and their treatment from the clinical records. Data on risk factors for atherosclerosis, medications used, and radiotherapy were also collected. Images were analyzed to determine the timing of development of CAS, identify significant (\>50%) CAS using the North American Symptomatic Carotid Endarterectomy Trial criteria, and calculate the total plaque score (TPS) and wall thickness. The purpose of this study was to determine the incidence of ICVE and of CAS in patients who receive radiotherapy for HNC and the risk factors for CAS.

Conditions

Carotid Artery Stenosis; Head and Neck Cancer; Radiation Therapy; Transient Ischemic Attack; Ischemic Stroke

Keywords

Carotid artery stenosis; Head and neck cancer; Radiation therapy; Transient ischemic attack; Ischemic stroke; Thailand

Outcome Measures

Primary Outcomes (1)

• Incidence of ischemic cerebrovascular event after radiotherapy. (Percentage of partcipants who developed ischemic stroke or transient ischemic attack following completion of radiotherapy in all participants)

  The cumulative incidence of ischemic cerbrovascular event including ischemic stroke or transient ischemic attack in the anterior circulation in HNC patient who receive radiotherapy in 5 years

  5 years

Secondary Outcomes (2)

• The risk factors that were identified to influence development of new carotid artery stenosis

  through study completion, an average of 1 year

• Incidence of carotid artery stenosis at 12, 24, and 36 months after radiotherapy (Percentage of partcipants who develop carotid artery stenosis)

  12, 24, 36 months

Study Arms (1)

HNC patient who recieve RT

Reviewing medical record of all patiented who receive radiotherapy and focusing in ischemic cerebrovascular event and carotid artery stenosis. We categorized the patiented to 3 group : no carotid artery stenosis, seen carotid artery stenosis and seen significant carotid artery stenosis and find the risk factor of preexisting carotid artery stenosis before RT

Radiation: Radiotherapy

Interventions

Radiotherapy RADIATION

Review imaging and medical record of head and neck cancer patient who recieve radiotherpy to find out the incidence of ischemic cerebrovascular event and carotid artery stenosis. The risk factor that influence new carotid artery stenosis was claculated

HNC patient who recieve RT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with HNC involving the oral cavity, pharynx, larynx, nasal cavity, or salivary glands.

You may qualify if:

• All patients underwent radiotherapy to the head and neck region between February 2011 and June 2022 with or without surgical resection and were investigated by computed tomography (CT) before and after radiotherapy.

You may not qualify if:

• Patients with lymphoma and those with previous treatment for CAS or radiotherapy for other diseases were excluded.

Sponsors & Collaborators

• Chulabhorn Royal Academy: lead

Study Sites (1)

Department of Surgery, Chulabhorn Hospital, Princess Srisavangavadhana College of Medicine, Chulabhorn Royal Academy, Bangkok, Thailand

Bangkok, 10210, Thailand

Location

MeSH Terms

Conditions

Carotid Stenosis; Head and Neck Neoplasms; Ischemic Attack, Transient; Ischemic Stroke

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Neoplasms by Site; Neoplasms; Brain Ischemia; Stroke

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Nawaphan Taengsakul Taengsakul, MD

  Chulabhorn Royal Academy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 16, 2024
• Study Start: January 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: February 1, 2024
• Last Updated: August 16, 2024

Record last verified: 2024-08

Locations

TH (1)