Head and Neck CancerNCT05490875
Carotid Ultrasound to Identify Head and Neck Cancer Survivors With High Cardiovascular Risk After Radiation Therapy
An observational study of Head and Neck Cancer and Carotid Artery Stenosis, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Carotid Artery Stenosis, Cardiovascular Complication
- What is being tested?
- Carotid ultrasound, Blood draw and Survey
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2022to 7 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
About this study
Official title: A Pilot Study of Carotid Ultrasound to Identify Head and Neck Cancer Survivors With High Cardiovascular Risk After Radiation Therapy
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.
Read the 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.
- Being tested
- Carotid ultrasound, Blood draw, Survey
- Medical subject headings
- Head and Neck Neoplasms, Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid ultrasoundProcedure or surgery
Carotid ultrasound will be done to both sides of the neck to look at the carotid arteries.
Blood drawOther
This optional blood draw could occur anytime from the time of enrollment on the study until 90 days after the research ultrasound.
SurveyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Carotid ultrasound; Other: Blood draw; Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At study completion, up to 1 approximately year
Secondary outcomes (9)
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.
Measured: At time of ultrasound, up to approximately 1 year
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.
Measured: At time of ultrasound, up to approximately 1 year
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.
Measured: At time of ultrasound, up to approximately 1 year
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.
Measured: 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
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
Measured: At time of ultrasound, up to approximately 1 year
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.
Measured: At time of enrollment, up to approximately 1 year
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.
Measured: At study completion, up to approximately 1 year
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.
Measured: At study completion, up to approximately 1 year
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.
Measured: At study completion, up to approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start2 Dec 2022
- Primary completion7 Jan 2025
- Study completion7 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan Hughes, MD, Principal investigator, Wake Forest Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490875
- Sponsor's protocol ID
- IRB00087922
- Other IDs
- WFBCCC 98322
- Status last verified
- Jan 2025
- First submitted
- 4 Aug 2022
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39230469
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Carotid Ultrasound to Identify Head and Neck Cancer Survivors With High Cardiovascular Risk After Radiation Therapy
- ClinicalTrials.gov ID
- NCT05490875
- Acronym / sponsor ID
- IRB00087922
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carotid Ultrasound Group | – | Procedure: Carotid ultrasound, Other: Blood draw, Other: SurveyHead 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carotid ultrasoundCarotid ultrasound will be done to both sides of the neck to look at the carotid arteries. | Procedure or surgery | Carotid Ultrasound Group |
| Blood drawThis optional blood draw could occur anytime from the time of enrollment on the study until 90 days after the research ultrasound. | Other | Carotid Ultrasound Group |
| SurveyParticipants 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. | Other | Carotid Ultrasound Group |
Primary outcome
Number of Participants with 50% Stenosis Identified
Time frame: At study completion, up to 1 approximately year
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.
9 secondary outcomes
Change in Intima-Media Thickness (IMT)
Time frame: At time of ultrasound, up to approximately 1 year
Number of Participants with Carotid Intima-Media Thickness (IMT) Increase
Time frame: At time of ultrasound, up to approximately 1 year
Number of Participants with Carotid Plaque Thickness Increase
Time frame: At time of ultrasound, up to approximately 1 year
Number of Participants Identified at High Risk of Cardiovascular Events
Time frame: 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
Time frame: At time of ultrasound, up to approximately 1 year
Number of Participants Enrolled that Receive Study Intervention - Feasibility
Time frame: At time of enrollment, up to approximately 1 year
Acceptability of Intervention Measure Instrument (Likert scale).
Time frame: At study completion, up to approximately 1 year
Barriers Survey instrument (Likert scale)
Time frame: At study completion, up to approximately 1 year
Assessment of Risk Perception Instrument (Likert scale)
Time frame: At study completion, up to approximately 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Derived from this study: PubMed 39230469Hughes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Hughes, MD principal investigator
Wake Forest Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Carotid Artery Stenosis, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with 50% Stenosis Identified (time frame: At study completion, up to 1 approximately year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05490875, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.