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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

Tracking Information
First Submitted Date February 6, 2014
First Posted Date February 12, 2014
Last Update Posted Date February 12, 2014
Study Start Date October 2011
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 10, 2014)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: February 10, 2014)
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Cross-sectional Study Looking at the Effect of Radiotherapy on Carotid Intima-medial Thickness in Head and Neck Cancer
Official Title A Cross-sectional Study Looking at the Effect of Radiotherapy on Carotid Intima-medial Thickness in Head and Neck Cancer
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Head and Neck Tumours
Intervention Not Provided
Study Groups/Cohorts Cross-sectional hemi-neck RT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 10, 2014)
50
Original Actual Enrollment Same as current
Actual Study Completion Date November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02060643
Other Study ID Numbers CCR 3687
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Royal Marsden NHS Foundation Trust
Study Sponsor Royal Marsden NHS Foundation Trust
Collaborators Royal Brompton and Harefield NHS Foundation Trust
Investigators
Principal Investigator: Christopher M Nutting, PhD Royal Marsden NHS Foundation Trust
PRS Account Royal Marsden NHS Foundation Trust
Verification Date February 2014