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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05490875
• Other study ID #: IRB00087922
• Secondary ID: WFBCCC 98322
• Status: Recruiting
• Start date: December 2, 2022
• Est. completion date: June 2025

Study information

• Verified date: December 2023
• Source: Wake Forest University Health Sciences
• Contact: Study Coordinator
• Phone: 336-716-4464
• Email: ryhughes[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Complication
• Carotid Artery Stenosis
• Carotid Stenosis
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Procedure:
• Carotid ultrasound
Carotid ultrasound will be done to both sides of the neck to look at the carotid arteries.

Other:
• Blood draw
This optional blood draw could occur anytime from the time of enrollment on the study until 90 days after the research ultrasound.
• Survey
Participants will complete a 15-minute survey about how acceptable participants find the ultrasound procedure, whether participants would be open to it in the future if a doctor thought it was necessary, whether participants would be open to getting treatment for artery problems, and how participants feel about their own risk of stroke.

Locations

Country	Name	City	State
United States	Wake Forest Baptist Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with 50% Stenosis Identified	This will be defined as having a peak systolic flow velocity of 150 cm/s or higher on Doppler ultrasonography will be estimated and reported along with an exact 95% confidence interval.	Up to 1 year
Secondary	Change in Intima-Media Thickness (IMT)	Mean, median, standard deviation and interquartile range will be used to describe IMT as a continuous variable at three separate angles (anterior, lateral and posterior). IMT will be measured in millimeters at 3 separate angles (anterior, lateral, and posterior) at the level of the distal common carotid artery, carotid bulb at the flow divider, and the proximal internal carotid artery.	Up to 2 years
Secondary	Number of Participants with Carotid Intima-Media Thickness (IMT) Increase	Participants with at least one carotid IMT measurements of 0.9 mm or greater based on IMT measurements will be each be estimated and reported along with an exact 95% confidence interval.	Up to 2 years
Secondary	Number of Participants with Carotid Plaque Thickness Increase	Participants with carotid plaque of maximum thickness 2 mm or greater and with high risk of cardiovascular events (relative risk 1.50 or greater) based on IMT measurements will be each be estimated and reported along with an exact 95% confidence interval.	Up to 2 years
Secondary	Number of Participants Identified at High Risk of Cardiovascular Events	Participants identified as clinically significant (relative risk 1.50 or greater) may be estimated and reported along with an exact 95% confidence interval within subgroups defined by clinical characteristics.	Up to 2 years
Secondary	Number of Participants with Clinically Significant Carotid Artery Stenosis (Greater than or Equal to 50%) Based on Potential Risk Factors	Associations between continuous clinical characteristics and clinically significant carotid artery stenosis will be evaluated using t-tests or Wilcoxon rank-sum tests. Potential risk factors used to evaluate will be gender; age; systolic blood pressure at time of ultrasound; history of cigarette smoking; history of prior cardiovascular disease; history of atrial fibrillation; left ventricular hypertrophy on echocardiogram; use of anti-hypertensive medication; radiation dose to the exposed carotid artery	Up to 2 years
Secondary	Number of Participants Enrolled that Receive Study Intervention - Feasibility	The study will be considered feasible if 60% of responding participants enroll and receive carotid ultrasound. If less than 40% of responding participants enroll and receive the study carotid ultrasound, investigators will re-evaluate methods for subsequent study. This will be be reported with an exact 95% confidence interval.	Up to 2 years
Secondary	Acceptability of Intervention Measure Instrument (Likert scale).	Descriptive statistics will be used to characterize acceptability of carotid ultrasound. Scoring scale is a Likert scale (completely disagree to completely agree) with completely agree being scored as a more positive response to the intervention and treatment options.	Up to 2 years
Secondary	Barriers Survey instrument (Likert scale)	Descriptive statistics will be used to characterize barriers to getting a carotid ultrasound. Scoring scale is a Likert scale (completely disagree to completely agree) with completely agree being scored as a more positive response to the intervention and/or treatment options.	Up to 2 years
Secondary	Assessment of Risk Perception Instrument (Likert scale)	Descriptive statistics will be used to characterize stroke risk perception. Scoring scale is a Likert scale (completely disagree to completely agree) with completely agree being scored as a more positive response to the intervention and/or treatment options.	Up to 2 years