Ketotifen: Novel Use as a Cardioprotective Agent in Breast Cancer Patients Receiving Anthracycline-containing Chemotherapy as Well as the Potential Beneficial Effects of Ketotifen in the Hypothetical Management of COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- prophylaxis effect of Ketotifen on patient's hearts during the treatment of anthracyclines
研究概览
简要总结
The objective of our study was to evaluate the expected cardioprotective effects of ketotifen due to its activity as an iron-chelating agent previously uncovered by us in the in vitro chemical test which included in the study, when used in patients receiving anthracyclines for the treatment of breast cancer. The study was a randomized : , prospective controlled trial : , and the patients were identified by coded numbers to maintain privacy. Eligible patients (111) fulfilled the criteria. Control Group: 55 patients received their standard therapy (anthracycline-containing chemotherapy without ketotifen). Ketotifen Group: 56 patients received anthracycline-containing chemotherapy plus ketotifen as a cardioprotective agent. Ketotifen will be given orally as one tablet (1 mg/tablet) 3 times daily, before and during the chemotherapeutic cycle for 6 cycles of treatment. Blood samples were obtained from all patients, and echocardiography two times for each patient at baseline and after 6 months (EF%).
详细描述
The objective of our study was to evaluate the expected cardioprotective effects of ketotifen due to its activity as an iron-chelating agent previously uncovered by us in the in vitro chemical test which included in the study, when used in patients receiving anthracyclines for the treatment of breast cancer. The study was a randomized : , prospective controlled trial : , and the patients were identified by coded numbers to maintain privacy. Eligible patients (111) fulfilled the criteria. Control Group: 55 patients received their standard therapy (anthracycline-containing chemotherapy without ketotifen). Ketotifen Group: 56 patients received anthracycline-containing chemotherapy plus ketotifen as a cardioprotective agent. Ketotifen will be given orally as one tablet (1 mg/tablet) 3 times daily, before and during the chemotherapeutic cycle for 6 cycles of treatment. Blood samples were obtained from all patients, and echocardiography two times for each patient at baseline and after 6 months (EF%).
The aim is to prove and evaluate the prophylasis effect of ketotifin from cardiotoxicity induced by anthracyclines therapy without decreasing the anti-tumor action of anthracycline.
Because coronaviruses theoretically induce iron overload so, ketotifen has a potential beneficial effect in the management of COVID-19 as well.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •cancer patients receiving anthracycline chemotherapy in their protocol alone (without any cardioprotective agent),
- •aged 30-60, and
- •female subjects were included as they were female breast cancer patients, and,
- •patients who had an adequate baseline echocardiography.
排除标准
- •who had a history of heart failure,
- •arrhythmia,
- •cardiac catheterizations,
- •uncontrolled hypertension, and
- •uncontrolled diabetes,
- •patients with impaired liver function tests,
- •patients who previously received anthracycline-containing regimens, and
- •any cardiotoxic chemotherapy regimens, previous history of chest wall irradiation.
- •Brian metastasis.
研究组 & 干预措施
control group
55 patients received their standard therapy (anthracycline-containing chemotherapy without ketotifen)
干预措施: Ketotifen 1 MG (Drug)
ketotifen group
Ketotifen Group: 56 patients received anthracycline-containing chemotherapy plus ketotifen as a cardioprotective agent. Ketotifen will be given orally as one tablet (1 mg/tablet) 3 times daily, before and during the chemotherapeutic cycle for 6 cycles of treatment
干预措施: Ketotifen 1 MG (Drug)
结局指标
主要结局
prophylaxis effect of Ketotifen on patient's hearts during the treatment of anthracyclines
时间窗: 6 months
the serum levels of LDH, CK-MB, troponin I, TIBC, ferritin, anti-cardiolipin IgG, and, iron were done
次要结局
未报告次要终点
研究者
hosny ahmed elewa
head of pharmacy practice department
Horus University