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临床试验/CTRI/2025/07/091379
CTRI/2025/07/091379尚未招募不适用

CRoss-sectional study assessing long term carotid Artery Stenosis in Head and neck cancer patients receiving radiotherapy to neck. (CRASH Study)

TRAC1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2025年8月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
108
试验地点
1
主要终点
Prevalence of moderate and severe long-term RT induced CAS and corelation with RT dose in patients of head neck cancers who received RT to neck

研究概览

简要总结

Patients of head and neck cancers receive radiotherapy as part of their treatment and radiation therapy can sometimes lead to a narrowing or thickening of the carotid arteries, a condition called carotid artery stenosis i.e. Narrowing of carotid artery leads to decreased blood supply to the brain and development of stroke. The risk of carotid artery stenosis increases with higher radiation doses, older age, smoking, and other health conditions like high blood pressure and diabetes. However, the condition may not cause symptoms in its early stages and remain asymptomatic in most patients. The risk of carotid artery increases as year passes by after radiotherapy. The overall risk of carotid artery stenosis is around 26%. There is no definitive guideline as to whether to evaluate this risk or not and when to do it, its impact on the survival of patients. Hence in this study, we aim to assess the rate and extent of carotid artery stenosis using a non-invasive method called USG Doppler. This study aimed to explore the effects of radiation treatment on the carotid arteries in patients who have been treated for head and neck cancer. The carotid arteries are the major blood vessels that supply blood to the brain, and damage to these arteries can lead to serious health problems, like stroke. By examining patients who have received radiation for head and neck cancer, this study sought to understand how common this narrowing of the arteries is, how severe it can get, and which factors may influence its development. The research involved analyzing the medical records and conducting tests to measure the degree of narrowing in the carotid arteries in a group of patients. The findings of this study could help doctors identify head and neck cancer patients who are at higher risk for carotid artery stenosis, enabling earlier detection and better management of this potential complication.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1 Cancers of oral cavity, Carcinoma of unknown primary, oropharynx, larynx and hypopharynx who have received RT to unilateral or bilateral neck with or without concurrent Chemotherapy
  • Received RT dose to neck greater than 50GY
  • Patients treated with IMRT technique
  • Post RT at least 3 yr.

排除标准

  • Not received RT to neck
  • Those not treated with IMRT
  • Nasopharyngeal cancer
  • Less than 3yr from treatment completion.
  • T1-T2 glottis cancer
  • Received re-irradiation
  • Metastatic disease at presentation
  • Recurrent disease at the time of evaluation for CAS 7.

结局指标

主要结局

Prevalence of moderate and severe long-term RT induced CAS and corelation with RT dose in patients of head neck cancers who received RT to neck

时间窗: Post Radiation 3 years

次要结局

未报告次要终点

研究者

发起方
TRAC
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Monali swain

head and neck DMG

研究点 (1)

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