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

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ClinicalTrials.gov Identifier: NCT02060643
Recruitment Status : Completed
First Posted : February 12, 2014
Last Update Posted : February 12, 2014
Sponsor:
Collaborator:
Royal Brompton and Harefield NHS Foundation Trust
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

Brief 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.

Condition or disease
Head and Neck Tumours

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Cross-sectional Study Looking at the Effect of Radiotherapy on Carotid Intima-medial Thickness in Head and Neck Cancer
Study Start Date : October 2011
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


Group/Cohort
Cross-sectional hemi-neck RT



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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. 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

  3. 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

  4. 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

  5. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Adult patients with histologically confirmed cancer or benign tumours of the head and neck area treated with hemi-neck radiotherapy to ≥ 50Gy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060643


Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Royal Brompton and Harefield NHS Foundation Trust
Investigators
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Principal Investigator: Christopher M Nutting, PhD Royal Marsden NHS Foundation Trust

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Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02060643     History of Changes
Other Study ID Numbers: CCR 3687
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: February 12, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms