跳至主要内容
临床试验/CTRI/2025/02/081016
CTRI/2025/02/081016尚未招募不适用

Radiation doses to cardiac substructures as a surrogate marker of cardio-toxicity in left breast cancer

All India Institute of Medical Sciences, Jodhpur1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年3月3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
30
试验地点
1
主要终点
- Correlation of Doses to heart and cardiac substructures with biochemical, radiological and other markers of cardiac injury

研究概览

简要总结

The most prevalent cancer diagnosed worldwide and among Indian women is now female breast cancer, surpassing lung cancer in prevalence. As per a meta-analysis by EBCTCG, radiotherapy showed an absolute reduction of 15.7% in the 10-year risk of any (ie, locoregional or distant) first recurrence with a modest benefit in overall survival as well. Large cohorts of cancer survivors who underwent RT, either alone or in conjunction with other modalities, are susceptible to late treatment-related complications. Delayed effects on the heart may partially counterbalance the therapeutic benefits of RT, negating those advantages. Virtually any component of the heart can be harmed by exposing a sizable portion of it to radiation at a high enough dose. The main pathophysiology behind this is shown to entail blood vessel injury. Reactive oxygen species are hypothesised to be responsible for this damage by disrupting DNA strands. Fibrosis follows secondary inflammatory alterations. This then leads to a vicious cascade of events such as intimal fibrosis, atherosclerosis, decreased coronary perfusion and other ischemic or conduction abnormalities. Although vessel injury is postulated to be a major player in the cardiac events associated with breast cancer radiation, Mean heart dose rather than doses to various cardiac substructures still remain the standard of care at most centres while prescribing dose constraints during Breast radiotherapy in the absence of strong conclusive data. Thus, the objective of this study is to assess the correlation between Mean cardiac dose, doses to cardiac substructures and their contribution to cardiac events.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Biopsy proven patients of left breast cancer, planned for post-operative adjuvant radiation
  • Age 18-65 years
  • Absence of pre-existing cardiac condition.

排除标准

  • Patients treated with palliative intent.
  • Patient of right breast cancer
  • Patients not giving consent for participation.
  • Patient who received prior radiation.

结局指标

主要结局

- Correlation of Doses to heart and cardiac substructures with biochemical, radiological and other markers of cardiac injury

时间窗: 3 and 6 months post radiation

- Correlation of Doses to Left anterior descending artery, Left coronary artery and Left ventricle with Mean heart dose.

时间窗: 3 and 6 months post radiation

次要结局

  • To evaluate various clinicopathological predictors which correlate with presence of cardiac events.(3 and 6 months post radiation)

研究者

发起方
All India Institute of Medical Sciences, Jodhpur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Akanksha Solanki

All India Institute of Medical Science,Jodhpur

研究点 (1)

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