To hear about similar clinical trials, please enter your email below
Trial Title:
Carotid Ultrasound to Identify Head and Neck Cancer Survivors With High Cardiovascular Risk After Radiation Therapy
NCT ID:
NCT05490875
Condition:
Head and Neck Cancer
Carotid Artery Stenosis
Cardiovascular Complication
Conditions: Official terms:
Head and Neck Neoplasms
Carotid Stenosis
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Carotid ultrasound
Description:
Carotid ultrasound will be done to both sides of the neck to look at the carotid
arteries.
Arm group label:
Carotid Ultrasound Group
Intervention type:
Other
Intervention name:
Blood draw
Description:
This optional blood draw could occur anytime from the time of enrollment on the study
until 90 days after the research ultrasound.
Arm group label:
Carotid Ultrasound Group
Intervention type:
Other
Intervention name:
Survey
Description:
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.
Arm group label:
Carotid Ultrasound Group
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Wake Forest Baptist Comprehensive Cancer Center
Address:
City:
Winston-Salem
Zip:
27157
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Email:
mzayas@wakehealth.edu
Start date:
December 2, 2022
Completion date:
June 2025
Lead sponsor:
Agency:
Wake Forest University Health Sciences
Agency class:
Other
Source:
Wake Forest University Health Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05490875