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

NCT ID: NCT05490875

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-02
• Study Completion Date: 2025-01-07

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.

Conditions

Head and Neck Cancer; Carotid Artery Stenosis; Cardiovascular Complication

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Carotid Ultrasound Group

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.

Carotid ultrasound

Intervention Type: PROCEDURE

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

Blood draw

Intervention Type: OTHER

This optional blood draw could occur anytime from the time of enrollment on the study until 90 days after the research ultrasound.

Survey

Intervention Type: OTHER

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.

Interventions

Carotid ultrasound

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

Intervention Type: PROCEDURE

Blood draw

This optional blood draw could occur anytime from the time of enrollment on the study until 90 days after the research ultrasound.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan Hughes, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest Comprehensive Cancer Center

Locations

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Countries

United States

References

Hughes RT, Snavely AC, Dressler EV, Tegeler CH, Nightingale CL, Furdui CM, Soto Pantoja DR, Register TC, Weaver KE, Lesser GJ. Carotid ultrasound to identify head and neck cancer survivors with high cardiovascular risk after radiation therapy: rationale and design of a prospective, cross-sectional pilot study. Future Oncol. 2024;20(31):2331-2341. doi: 10.1080/14796694.2024.2386927. Epub 2024 Sep 4.

Reference Type: DERIVED

PMID: 39230469 (View on PubMed)

Other Identifiers

WFBCCC 98322

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00087922

Identifier Type: -

Identifier Source: org_study_id