Head and Neck Tumours Clinical Trial
Official title:
A Cross-sectional Study Looking at the Effect of Radiotherapy on Carotid Intima-medial Thickness in Head and Neck Cancer
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 carotid arteries are often
included in the radiotherapy as collateral structures. There is some evidence to show that
radiotherapy to these blood vessels can result in thickening of the artery walls some years
after treatment and increased risk of stroke or TIA in the future.
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 measure the thickness (intima-medial thickness) of irradiated
carotid artery walls and compare this to unirradiated arteries. 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 have only had one side of their neck treated and use the other side as a comparison. The
study will also be looking 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, the mean intimal-medial thickness will be the same
compared to unirradiated arteries.
- Serum biomarkers will not be elevated in radiation-induced carotid atherosclerosis.
- Development of radiation-induced carotid atherosclerosis is not affected by risk factor
modulation (Aspirin, HMGCoA reductase inhibitors, smoking cessation).
- There is no difference in carotid arterial wall strain in irradiated carotid arteries
versus unirradiated carotid arteries.
- Microbubble ultrasound will not be able to detect Inflammation in the carotid arteries
as an early marker of atherosclerosis.
n/a
Observational Model: Cohort, Time Perspective: Cross-Sectional
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02069964 -
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
|
N/A |