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

10 februari 2014 uppdaterad av: Royal Marsden NHS Foundation Trust

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.

Studieöversikt

Status

Avslutad

Studietyp

Observationell

Inskrivning (Faktisk)

50

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

N/A

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

Adult patients with histologically confirmed cancer or benign tumours of the head and neck area treated with hemi-neck radiotherapy to ≥ 50Gy

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Cross-sectional hemi-neck RT

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The difference in mean IMT between irradiated and unirradiated carotid arteries.
Tidsram: >2 years post-radiotherapy
Cross-sectional study - measured at one time-point at least 2 years after radiotherapy
>2 years post-radiotherapy

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The prevalence of carotid artery stenosis in irradiated carotid arteries compared to unirradiated carotid arteries.
Tidsram: >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.
Tidsram: > 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.
Tidsram: > 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
Tidsram: > 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
Tidsram: > 2 years post-radiotherapy
Cross-sectional - measured at one time point at least 2 years after radiotherapy
> 2 years post-radiotherapy

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Christopher M Nutting, PhD, Royal Marsden NHS Foundation Trust

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2011

Primärt slutförande (Faktisk)

1 november 2013

Avslutad studie (Faktisk)

1 november 2013

Studieregistreringsdatum

Först inskickad

6 februari 2014

Först inskickad som uppfyllde QC-kriterierna

10 februari 2014

Första postat (Uppskatta)

12 februari 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

12 februari 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 februari 2014

Senast verifierad

1 februari 2014

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • CCR 3687

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