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临床试验/NCT07668076
NCT07668076已完成2 期

The Potential Cardioprotective Effect of Addition of Atorvastatin in Breast Cancer Patients Treated With Doxorubicin-based Chemotherapy

Damanhour University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2022年11月15日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
44
试验地点
1

研究概览

简要总结

the study aims to evaluate the cardioprotective effect of atorvastatin in breast cancer female patients treated with doxorubicin based chemotherapy

详细描述

female patients with newly diagnosed breast cancer, who are candidates for AC protocol will be recruited from Damanhour oncology center.

All enrolled patients will be randomly assigned into 2 arms:

  • Control arm : will receive AC regimen only (doxorubicin 60 mg/m² IV + cyclophosphamide 600 mg/m² IV) for 4 cycles every 21 days.
  • Atorvastatin arm : will receive AC regimen mentioned above + atorvastatin 40 mg orally once daily for 3 months.

All patients will be submitted to:

  • Full patient history and clinical examination.
  • Routine follow up before and after each chemotherapy cycle (complete blood picture, liver function tests, renal function tests).
  • Echocardiography also will be obtained at the time of admission.
  • Serum samples will be collected from patients at the time of admission for measuring the cardiac biomarkers in addition to serum cholesterol level.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with newly diagnosed breast cancer and ≥ 18 years old.
  • Naive to chemotherapy.
  • Left ventricular ejection fraction (LVEF) > 55%.

排除标准

  • Concurrent administration of any other cholesterol-lowering therapy.
  • Evidence of hepatic dysfunction (alanine aminotransferase level more than three times the upper limit of the normal range)
  • Evidence of renal dysfunction (creatinine level more than three times the upper limit of the normal range).
  • Predisposing factors for rhabdomyolysis, including hypothyroidism, reduced renal function, any muscle or liver disease.
  • Concurrent administration of potent CYP3A4-inhibitors.
  • Pregnancy or breast-feeding

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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