A Prospective Longitudinal Cohort Study Looking at the Difference in Carotid Intima-medial Thickness Between Irradiated and Unirradiated Carotid Arteries in Patients With Head and Neck Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2017-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Some patients with head and neck cancer or benign tumours of the head and neck receive radiotherapy to their neck as part of their treatment. The large arteries in the neck, the carotid arteries, are often included in the area being treated with radiotherapy. There is some evidence to show that radiotherapy to these blood vessels can result in thickening and furring of the artery walls some years after treatment. This thickening may then result in stiffening and narrowing of the artery.

Current research is now aimed towards detecting radiotherapy-related changes to the carotid arteries at an earlier stage and towards using new radiotherapy techniques to avoid treating these blood vessels if possible. The question of whether or not the use of preventive medicines like aspirin and cholesterol-lowering tablets helps to reverse this process is currently unanswered.

The aim of this study is to compare the thickness (intima-medial thickness) of the carotid artery wall over time (a period of 5 years) following radiotherapy to the thickness in carotid arteries that have not received radiotherapy. There are many other causes for thickening of arteries (such as high blood pressure, high cholesterol levels and diabetes) and these may affect the ability to measure the effect of radiotherapy change to the artery wall. In order to address this, it is ideal to look at this process in patients who are having only one side of the neck treated and use the other side as a comparison. The study will also be investigating for earlier signs of radiotherapy-related changes, such as stiffening of the artery wall, inflammation in the artery wall (a very early sign of radiotherapy-related change) and some markers in the blood that may indicate that this process is taking place.

The null hypotheses of this study are:

* In irradiated carotid arteries, mean intimal-medial thickness at one year following radiotherapy will be the same as in unirradiated arteries.
* The incidence of carotid artery stenosis will be the same in irradiated and unirradiated carotid arteries
* Arterial wall strain at one year following radiotherapy will be the same in irradiated and unirradiated carotid arteries.
* Microbubble ultrasound will not be able to detect Inflammation in the carotid arteries during radiotherapy as an early marker of atherosclerosis; microbubble ultrasound will not demonstrate at what dose of radiotherapy inflammation begins.
* Serum biomarker levels will not increase over time from baseline after radiotherapy and won't correlate to IMT and arterial strain.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Cross-sectional Study Looking at the Effect of Radiotherapy on Carotid Intima-medial Thickness in Head and Neck Cancer

NCT02060643

Head and Neck Tumours

COMPLETED

Radiation-associated Carotid Artery Disease in Patients With Nasopharyngeal Carcinoma

NCT03568032

Nasopharyngeal Carcinoma Carotid Artery Diseases

UNKNOWN

Carotid Artery Stenosis and Ischemic Cerebrovascular Events After Radiotherapy in Patients With Head and Neck Cancer

NCT06556979

Carotid Artery Stenosis Head and Neck Cancer Radiation Therapy +2 more

COMPLETED

Carotid Revascularization for Radiation Induced Carotid Artery Stenosis

NCT05134246

Radiation-induced Carotid Artery Stenosis

RECRUITING

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

NCT05490875

Head and Neck Cancer Carotid Artery Stenosis Cardiovascular Complication

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Head and Neck Tumours

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Prospective hemi-neck RT

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Be 18 years or older
* Histologically confirmed cancer or benign tumours of the head and neck area requiring ≥ 50Gy to one side of the neck (conventional or intensity modulated RT)
* Prior or subsequent neck dissection allowed (irradiated and/or unirradiated side)
* Be able to provide written informed consent

Exclusion Criteria

* Patients with bulky nodal neck disease that may interfere with acquisition of ultrasound images
* Patients with a prior history of carotid endarterectomy or carotid angioplasty and stenting

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No