Evaluation of the Cardioprotective Effect of Dapagliflozin on Anthracyclines-Induced Cardiotoxicity in Breast Cancer Patients
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- N-terminal pro-B-type natriuretic peptide (NT-pro BNP) testing
研究概览
简要总结
The goal of this clinical trial is to learn if dapagliflozin drug has a cardioprotective effect against anthracyclines-induced cardiotoxicity. It will also learn about the safety of dapagliflozin drug.
Aim of the study:
Evaluate cardioprotective effect and safety of dapagliflozin against anthracyclines-induced cardiotoxicity.
The main questions it aims to answer are:
- Does the drug lower the cardiotoxicity which induced by anthracyclines?
- What medical problems do participants have when taking dapagliflozin drug?
Treatment
- Anthracyclines by 4 cycles included doxorubicin 50-60 mg/m2 with cyclophosphamide 600 mg as a combination or epirubicin 90-100 mg/m2 with cyclophosphamide 600 mg as a combination.
- Dapagliflozin 10 mg tablet orally, once daily. Started 7 days before the first cycle of anthracyclines till the end of last anthracyclines dose.
详细描述
Breast cancer is a malignant tumor that originates in the cells of the breast tissue. It is the most common cancer in women worldwide, accounting for 24.2% of all cancer cases among women.
According to the latest World Health Organization statistics, there were an estimated 2.3 million new cases of breast cancer in 2020; it is the second leading cause of cancer death in women after lung cancer.
In Egypt, breast cancer is the most common malignancy in women, accounting for 38.8% of cancers in this population, with the estimated number of breast cancer cases nearly 22,700 in 2022 and forecasted to be approximately 46,000 in 2050.
Anthracyclines are well-established and highly effective anti-neoplastic agents, used to treat several adult and pediatric cancers, such as breast cancer, leukemia, lymphomas, sarcomas, and many others.
Anthracycline-induced cardiotoxicity typically manifests as a reduction in left ventricular ejection fraction (LVEF), cardiomyopathy, or symptomatic congestive heart failure (CHF).
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with pathologically proved invasive breast carcinoma.
- •Patients were indicated for anthracyclines containing adjuvant chemotherapy or new adjuvant anthracyclines.
- •Renal function (eGFR > 30 mL/minute per 1.73 m2 )
- •LVEF is more than 50 %
- •Age ≥ 18 and ≤ 60 years old
排除标准
- •patients with any cardiac condition that contraindicate the use of anthracyclines, like heart failure, arrythmia, stroke and myocardial infarction.
- •Previous anthracycline-containing regimens and any cardiotoxic chemotherapy regimens
- •pregnant or breastfeeding patients
- •patients receiving any other cardiotoxic agents.
- •Patients with diabetic ketoacidosis or patients with type 1 diabetes mellitus.
- •Mediastinal irradiation including heart.
- •Refusal to sign the written informed consent.
研究组 & 干预措施
Dapagliflozin group
Dapagliflozin group who consist of at least 20 breast cancer patients who receive 4 cycles of anthracyclines ( each cycle every 21 days ) with dapagliflozin 10 mg tablet once daily.
干预措施: Dapagliflozin 10mg Tab (Drug)
结局指标
主要结局
N-terminal pro-B-type natriuretic peptide (NT-pro BNP) testing
时间窗: Baseline and after the last cycle of anthracyclines ( 0 and 2 to 3 months from baseline)
Monitoring the serum at Baseline and after the last cycle of anthracyclines. Changes in serum NT-Pro BNP from baseline will be calculated and compared between groups
次要结局
- Echocardiography by measuring left ventricular ejection fraction (LVEF)(a) Baseline b) After the last cycle of anthracyclines (approximately 2 to 3 months from baseline) c) 3 months after the end of chemotherapy (approximately 5 to 6 months from baseline) d) As needed for any symptomatic patients)
研究者
Sara Mohamed Mohamed Abdel Motaleb
Lecturer of Clinical Pharmacy - Pharmacy Practice Department, Faculty of Pharmacy - Helwan University
Helwan University