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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02060643
• Other study ID #: CCR 3687
• Status: Completed
• Phase: N/A
• First received: February 6, 2014
• Last updated: February 10, 2014
• Start date: October 2011
• Est. completion date: November 2013

Study information

• Verified date: February 2014
• Source: Royal Marsden NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Be 18 years or older

• Histologically confirmed cancer or benign tumours of the head and neck area treated with hemi-neck radiotherapy to = 50Gy

• Received radiotherapy to the neck area more than 24 months previously

• Intervening neck dissection allowed

• Be able to provide written informed consent

Exclusion Criteria:

• Patients who have active head and neck cancer

• Patients with a prior history of carotid endarterectomy or carotid angioplasty and stenting

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Head and Neck Tumours

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust	Royal Brompton and Harefield NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in mean IMT between irradiated and unirradiated carotid arteries.	Cross-sectional study - measured at one time-point at least 2 years after radiotherapy	>2 years post-radiotherapy	No
Secondary	The prevalence of carotid artery stenosis in irradiated carotid arteries compared to unirradiated carotid arteries.	Cross-sectional - measured at one time point at least 2 years after radiotherapy	>2 years post-radiotherapy	No
Secondary	Quantify the use of risk-modifying therapy (anti-hypertensives, anti-diabetic medication, HMGCoA reductase inhibitors, smoking cessation) and their effect on radiation-induced carotid atherosclerosis.	Cross-sectional - measured at one time point at least 2 years after radiotherapy	> 2 years post-radiotherapy	No
Secondary	Correlation of serum biomarker levels to carotid IMT and strain.	Cross-sectional - measured at one time point at least 2 years after radiotherapy	> 2 years post-radiotherapy	No
Secondary	The difference in arterial wall strain between irradiated and unirradiated carotid arteries	Cross-sectional - measured at least 2 years after radiotherapy	> 2 years post-radiotherapy	No
Secondary	The difference in arterial wall inflammation between irradiated and unirradiated carotid arteries	Cross-sectional - measured at one time point at least 2 years after radiotherapy	> 2 years post-radiotherapy	No