NCT07668076已完成2 期
The Potential Cardioprotective Effect of Addition of Atorvastatin in Breast Cancer Patients Treated With Doxorubicin-based Chemotherapy
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
- 是
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
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
Cardioprotective Effect of Melatonin Versus Vitamin D in Breast Cancer Patients Receiving DoxorubicinNCT07349459Tanta University90
招募中
2 期
Prevention of cardiac Dysfunction during Adjuvant breast cancer therapy: A Randomized, Placebo-controlled, Multicenter Trial (PRADA-II)Breast cancer femaleHeart Failure2024-515323-11-00Akershus University Hospital214
尚未招募
不适用
Nala MammoReady and Nala CardiacReady are capable of identifying elevated risk among cases in comparison to controls for study participants to enhance the screening initiativesCTRI/2025/09/094544NALAGENETICS PTE LTD900
尚未招募
不适用
REstoring Metabolic FLEXibility Through Combined Exercise in Breast Cancer Survivors: A Randomized Controlled Trial.NeoplasmBreast CancerCancerNCT07405385University of Castilla-La Mancha44
Unknown
不适用
表阿霉素为基础药物化疗对合并糖尿病的早期乳腺癌患者的心脏毒性及右丙亚胺的保护作用ChiCTR-IPR-16007759自筹150
