- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02060643
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Cross-sectional hemi-neck RT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The difference in mean IMT between irradiated and unirradiated carotid arteries.
Time Frame: >2 years post-radiotherapy
|
Cross-sectional study - measured at one time-point at least 2 years after radiotherapy
|
>2 years post-radiotherapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The prevalence of carotid artery stenosis in irradiated carotid arteries compared to unirradiated carotid arteries.
Time Frame: >2 years post-radiotherapy
|
Cross-sectional - measured at one time point at least 2 years after radiotherapy
|
>2 years post-radiotherapy
|
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.
Time Frame: > 2 years post-radiotherapy
|
Cross-sectional - measured at one time point at least 2 years after radiotherapy
|
> 2 years post-radiotherapy
|
Correlation of serum biomarker levels to carotid IMT and strain.
Time Frame: > 2 years post-radiotherapy
|
Cross-sectional - measured at one time point at least 2 years after radiotherapy
|
> 2 years post-radiotherapy
|
The difference in arterial wall strain between irradiated and unirradiated carotid arteries
Time Frame: > 2 years post-radiotherapy
|
Cross-sectional - measured at least 2 years after radiotherapy
|
> 2 years post-radiotherapy
|
The difference in arterial wall inflammation between irradiated and unirradiated carotid arteries
Time Frame: > 2 years post-radiotherapy
|
Cross-sectional - measured at one time point at least 2 years after radiotherapy
|
> 2 years post-radiotherapy
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Christopher M Nutting, PhD, Royal Marsden NHS Foundation Trust
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCR 3687
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Head and Neck Tumours
-
Royal Marsden NHS Foundation TrustRoyal Brompton and Harefield NHS Foundation TrustUnknown
-
National Cancer Centre, SingaporeSingapore Translational Cancer Consortium; Genome Institute of Singapore; Cancer...RecruitingNon-small Cell Lung Cancer | Head and Neck Squamous Cell Carcinoma | Advanced Solid TumoursSingapore
-
Robert FerrisAmgenCompletedHead and Neck Cancer | Cancer of Head and Neck | Head Cancer | Neck Cancer | Neoplasms, Head and Neck | Cancer of the Head and Neck | Cancer of Neck | Upper Aerodigestive Tract Neoplasms | Neck Neoplasms | Cancer of the Head | Cancer of the Neck | UADT Neoplasms | Cancer of Head | Head Neoplasms | Head, Neck Neoplasms | Neoplasms, Head and other conditionsUnited States
-
IpsenTerminatedGastric Cancer | Colorectal Cancer | Bone Cancer | Squamous Cell Carcinoma of the Head and Neck | Advanced Cancer | Recurrent Disease | Pancreatic Ductal Adenocarcinoma | Metastatic TumoursUnited States, France, Belgium, Switzerland, Netherlands
-
Assiut UniversityRecruitingHead and Neck Cancer | Head and Neck Neoplasms | Cancer of Head and Neck | Neoplasms, Head and Neck | Cancer of the Head and NeckEgypt
-
Cancer Trials IrelandSouthampton Clinical Trials Unit; Region H Rigshospitalet; Centre Hospitalier...CompletedOesophageal Cancer | Adenocarcinoma of the Oesophagus | Adenocarcinoma of the Oesophago-gastric Junction | Oesophageal Tumours | Junctional TumoursIreland, United Kingdom, Denmark, France, Sweden
-
University of California, San FranciscoCompleted
-
AstraZenecaRecruitingHead and Neck Neoplasms | Colorectal Neoplasms | Advanced Solid Tumours | Carcinoma Non-small Cell LungUnited States, China, Korea, Republic of, Spain, Australia, Japan, Taiwan, Canada, France, Italy, Malaysia
-
IRCCS Policlinico S. MatteoNestlé Health Science Spain; Akern SrlCompletedHead-neck CancerItaly
-
IntraGel TherapeuticsNot yet recruiting