Clinical trial NCT05490875: Carotid Ultrasound to Identify Head and Neck Cancer Survivors With High Cardiovascular Risk After Radiation Therapy
Official title: A Pilot Study of Carotid Ultrasound to Identify Head and Neck Cancer Survivors With High Cardiovascular Risk After Radiation Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Carotid Artery Stenosis
Cardiovascular Complication
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be screened through the radiation oncology clinic and by review of the electronic medical record for visits with head and neck radiation therapy providers.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with 50% Stenosis Identified
timeFrame: At study completion, up to 1 approximately year
Secondary outcomes:
measure: Change in Intima-Media Thickness (IMT)
timeFrame: At time of ultrasound, up to approximately 1 year
measure: Number of Participants with Carotid Intima-Media Thickness (IMT) Increase
timeFrame: At time of ultrasound, up to approximately 1 year
measure: Number of Participants with Carotid Plaque Thickness Increase
timeFrame: At time of ultrasound, up to approximately 1 year
measure: Number of Participants Identified at High Risk of Cardiovascular Events
timeFrame: At time of ultrasound, up to approximately 1 year
measure: Number of Participants with Clinically Significant Carotid Artery Stenosis (Greater than or Equal to 50%) Based on Potential Risk Factors
timeFrame: At time of ultrasound, up to approximately 1 year
measure: Number of Participants Enrolled that Receive Study Intervention - Feasibility
timeFrame: At time of enrollment, up to approximately 1 year
measure: Acceptability of Intervention Measure Instrument (Likert scale).
timeFrame: At study completion, up to approximately 1 year
measure: Barriers Survey instrument (Likert scale)
timeFrame: At study completion, up to approximately 1 year
measure: Assessment of Risk Perception Instrument (Likert scale)
timeFrame: At study completion, up to approximately 1 year
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest Comprehensive Cancer Center
name: Ryan Hughes, MD
role: PRINCIPAL_INVESTIGATOR
References: