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.

Background: Radiation therapy is an integral component of treatment that can predispose to carotid artery stenosis (CAS) and increase the risk of cerebrovascular events for head and neck cancer survivors. The utility of screening for CAS with carotid ultrasound in asymptomatic head and neck cancer survivors is unclear. Methods: In this prospective, cross-sectional pilot study, 60 patients who have no evidence of cancer at least 2 years from completion of RT will undergo screening carotid ultrasound to identify patients with high risk of cardiovascular events. Results: Outcomes will include clinically significant CAS, carotid intima-media thickness, acceptability/feasibility of screening, barriers to care and preliminary data on changes to medical management because of screening. Correlative multi-omics analyses will examine biomarkers of CAS after radiation therapy. Conclusion: The results of this study will provide valuable data on the prevalence of CAS and preliminary patient-centered data that will inform the design of a future large-scale, multi-site clinical trial. Clinical Trial Registration:NCT05490875 (ClinicalTrials.gov) Plain Language Summary Patients with head and neck cancer are often treated with radiation therapy. Radiation therapy can cause damage to the blood vessels in the neck. This damage can manifest as narrowing of the blood vessels like the carotid artery, which can lead to stroke. Currently, it is not clear if screening head and neck cancer survivors with ultrasound scans of the carotid arteries is feasible or acceptable to patients. This has also not been formally assessed using a prospective clinical trial. In this study, patients with a history of head and neck cancer who have no evidence of their cancer for at least 2 years since completion of their radiation therapy will be enrolled. They will undergo blood testing and a research ultrasound of the carotid arteries to check for narrowing and other findings that may signal a high risk of stroke or another cardiovascular event. Participants will complete surveys on their experience with the process and how likely they are to accept further screening or additional treatment if something is found. They will also complete surveys on their perception of their personal risk of stroke and barriers to care that would prevent them from getting screening ultrasounds. Patients will be followed for up to 6 months after the ultrasound to check for any changes in their medical care that occurred because of the screening ultrasound. Article highlights Carotid artery stenosis in head & neck cancer survivors treated with radiation therapy Radiotherapy for head and neck (HN) cancer may increase the risk of accelerated atherosclerosis and late carotid artery stenosis (CAS) in 25% of patients, and screening of asymptomatic stenosis may be useful and cost-effective in specific high-risk populations. If clinically significant stenosis is identified, risk reduction strategies such as optimal medical management with or without procedural intervention may reduce the risk of stroke. Data supporting the use of carotid ultrasound (CUS) for HN cancer survivors are sparse, and no guideline currently recommends CUS screening for asymptomatic patients. Carotid ultrasound surveillance for detection of asymptomatic carotid artery stenosis after head & neck radiotherapy CUS allows for cardiovascular risk stratification using stenosis and intima-media thickness measurements. Knowledge gaps with regard to the use of CUS screening in this population include patient acceptability, feasibility, and clinical utility. Rates of change in medical management for screen-detected carotid stenosis in HN cancer survivors have not been assessed in a prospective study. Pilot trial of carotid artery ultrasound in head & neck cancer survivors In this single-institution trial, 60 patients with a history of HN cancer treated with radiotherapy will undergo screening CUS. Patients will be evaluated for CAS (peak systolic velocity by Doppler ultrasonography), and intima-media thickness will be measured. Outcomes include patient acceptability, feasibility, barriers to care and perceived stroke risk among participants. In patients with clinically significant stenosis, the rate of resultant medical interventions (e.g., new medication, additional imaging or intervention) will be determined. Conclusion This prospective study for CUS screening in HN cancer survivors will obtain novel preliminary data to better understand the utility and feasibility of a CUS screening program. Preliminary results will inform future trials focused on the efficacy and cost-effectiveness of carotid artery ultrasound screening in this patient population. Correlative analysis will elucidate novel biomarkers and mechanisms of post-radiotherapy CAS. [ABSTRACT FROM AUTHOR]