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

NCT05490875 | Completed

• 2 other identifiers: IRB00087922WFBCCC 98322
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Carotid Artery Stenosis; Cardiovascular Complication

Outcome Measures

Primary Outcomes (1)

• 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.

  At study completion, up to 1 approximately year

Secondary Outcomes (9)

• Change in Intima-Media Thickness (IMT)

  At time of ultrasound, up to approximately 1 year

• Number of Participants with Carotid Intima-Media Thickness (IMT) Increase

  At time of ultrasound, up to approximately 1 year

• Number of Participants with Carotid Plaque Thickness Increase

  At time of ultrasound, up to approximately 1 year

• Number of Participants Identified at High Risk of Cardiovascular Events

  At time of ultrasound, up to approximately 1 year

• Number of Participants with Clinically Significant Carotid Artery Stenosis (Greater than or Equal to 50%) Based on Potential Risk Factors

  At time of ultrasound, up to approximately 1 year

Study Arms (1)

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.

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

Interventions

Carotid ultrasound PROCEDURE

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

Carotid Ultrasound Group

Blood draw OTHER

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

Carotid Ultrasound Group

Survey 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.

Carotid Ultrasound Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• 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.

  PMID: 39230469 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood (total 16 mL) will be obtained from patients who opt to provide these samples. Plasma and peripheral blood mononuclear cells (PBMC) will be banked for the following planned correlative analyses, pending further funding. Upon collection, these samples will be collected (see Correlative Blood Specimen Collection Form), transported to and processed/stored by the NCORP Biorepository for future analysis. If funding is not obtained for correlative studies by the closure of this study, samples will be retained indefinitely for future study.

MeSH Terms

Conditions

Head and Neck Neoplasms; Carotid Stenosis

Interventions

Blood Specimen Collection; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ryan Hughes, MD

  Wake Forest Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 8, 2022
• Study Start: December 2, 2022
• Primary Completion: January 7, 2025
• Study Completion: January 7, 2025
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)