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.
調査の概要
状態
条件
研究の種類
入学 (実際)
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
|---|
|
Cross-sectional hemi-neck RT
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The difference in mean IMT between irradiated and unirradiated carotid arteries.
時間枠:>2 years post-radiotherapy
|
Cross-sectional study - measured at one time-point at least 2 years after radiotherapy
|
>2 years post-radiotherapy
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The prevalence of carotid artery stenosis in irradiated carotid arteries compared to unirradiated carotid arteries.
時間枠:>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.
時間枠:> 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.
時間枠:> 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
時間枠:> 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
時間枠:> 2 years post-radiotherapy
|
Cross-sectional - measured at one time point at least 2 years after radiotherapy
|
> 2 years post-radiotherapy
|
協力者と研究者
捜査官
- 主任研究者:Christopher M Nutting, PhD、Royal Marsden NHS Foundation Trust
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。