Carotid Ultrasound to Identify Head and Neck Cancer Survivors With High Cardiovascular Risk After Radiation Therapy

Wake Forest University (WFU)

Status: Completed

Conditions: Carotid Artery Stenosis; Cardiovascular Complication; Head and Neck Cancer

Treatments: Other: Survey; Other: Blood draw; Procedure: Carotid ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT05490875

WFBCCC 98322

IRB00087922

Details and patient eligibility

About

The purpose of this research study is to understand how radiation therapy may affect blood vessels in the neck called the carotid arteries. Investigators want to look at narrowing of the artery or thickening of the walls of the arteries.

Full description

Primary Objective: To determine the proportion of patients with clinically significant carotid artery stenosis (≥50% stenosis) in head and neck cancer survivors treated with head and neck radiotherapy.

Secondary Objectives:

• To measure the intima-media thickness (IMT) of the carotid arteries in head and neck cancer survivors treated with head and neck radiotherapy.
• To determine the proportion of patients with carotid intima-media thickness of at least 0.9 mm in head and neck cancer survivors treated with head and neck radiotherapy.
• To determine the proportion of patients with carotid plaque of maximum thickness 2 mm or greater in head and neck cancer survivors treated with head and neck radiotherapy.
• To determine the proportion of patients identified as having a high risk of cardiovascular events (relative risk 1.50 or greater) based on intima-media thickness measurements in head and neck cancer survivors treated with head and neck radiotherapy.
• To describe the risk of significant carotid artery stenosis based on various clinical factors in head and neck cancer survivors treated with head and neck radiotherapy.
• To determine the feasibility of carotid ultrasound in head and neck cancer survivors treated with head and neck radiotherapy.
• To obtain preliminary data on the acceptability of carotid ultrasound among head and neck cancer survivors treated with head and neck radiotherapy.
• To obtain preliminary data on barriers to potential carotid ultrasound screening in head and neck cancer survivors treated with head and neck radiotherapy.
• To obtain preliminary data on stroke risk perception among head and neck cancer survivors treated with radiotherapy in head and neck cancer survivors treated with head and neck radiotherapy.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of head and neck cancer treated with radiotherapy. Radiotherapy target volume(s) must have included at least one region of the neck to a total dose of at least 45 gray (Gy).
• At least 2 years since completion of radiotherapy with no evidence of disease at the time of last clinical follow-up.
• Eligible by Screening Questionnaire.
• Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).

Exclusion criteria

• Personal history of any of the following: Carotid artery stenosis on either side of the neck, stroke (CVA) or transient ischemic attack (TIA), carotid endarterectomy, carotid stent placement.
• Prior carotid artery ultrasound examination between completion of radiotherapy and registration.
• Most recent radiotherapy treatment was for any recurrence of a prior head and neck cancer and/or treatment for a subsequent head and neck cancer after diagnosis and treatment of an initial head and neck cancer.
• Any history of re-irradiation to the head and neck region. Re-irradiation is defined as a subsequent individual course of radiotherapy where the target overlaps a region of the head/neck that was previously targeted by the initial course of radiotherapy.
• ECOG Performance Status of 2 or greater.

Trial design

60 participants in 1 patient group

Carotid Ultrasound Group

Description:

Head and neck cancer survivors treated with radiotherapy, at least 2 years since end of radiotherapy with no evidence of disease will receive a carotid ultrasound to measure carotid velocities and intima-media thickness of the carotid arteries.

Treatment:

Procedure: Carotid ultrasound

Other: Blood draw

Other: Survey