Evaluating the Effect of Montelukast on Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- pro-BNP
研究概览
简要总结
This is a prospective, randomized (1:1) controlled trial that will be carried out on 50 patients who are candidate to evaluate the effect of montelukast on doxorubicin induced cardiotoxicity after 4 cycles of AC. Patients will be randomly allocated into two equal groups (25 patients each); group (A) for controlled (placebo), and group (B) for montelukast. Blood samples will be collected from the study subjects and analyzed for serum levels of the NF-KB and pro-BNP. Assessment of the biomarkers will be done at two time points: at baseline and after treatment with montelukast.
详细描述
The primary objective of this study is to evaluate the effect of montelukast on doxorubicin induced cardiotoxicity in breast cancer patients through assessing serum NT-proBNP and NF-KB. The secondary objective is to evaluate the safety and side effects of montelukast on doxorubicin induced cardiotoxicity in breast cancer patients.
Methodology and study design:
- Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University.
- About 50 patients who are candidate to the study will be recruited from Damanhour Cancer Institute.
- All participants will provide an informed consent.
- Demographic data; age (year), sex (female/male), weight (kg), height (cm), BMI (kg/m2) will be collected.
- About 5 ml of venous blood will be withdrawn by antecubital venipuncture from each participant at baseline and after receiving montelukast 10 mg once daily at bed time for 4 cycles of AC. At each time point blood samples will be collected into plain test tubes and centrifuged at 4500×g for 10 min and serum will be frozen at - 80 ◦C until analysis of the biomarkers using ELISA kits.
- Montelukast tablets will be provided on monthly intervals and the participants' adherence will be assessed through the medications refilling rate. Participants will also be followed-up by weekly telephone calls and monthly direct meetings to assess their adherence and report any drug related adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
prospective, single blind randomized (1:1) controlled trial
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult patients (age≥18 and≤ 70years old) with biopsy-confirmed diagnosis of breast cancer according to the American Joint Committee on Cancer (TNM staging system).
- •Patients with performance status (<2) according to Eastern Cooperative Oncology Group (ECOG).
- •Patients with adequate hematologic parameters (absolute neutrophil count≥1.5× 109/L, platelet count≥100× 109/L, hemoglobin level≥10 g/dl), adequate liver function (serum bilirubin<1.5 mg/dl), and adequate renal function (serum creatinine<1.5 mg/dl, creatinine clearance (CrCl)>45 ml/min).
排除标准
- •Patients who refuse to sign the written consent.
- •If blood cell counts are too low.
- •Severe liver problem.
- •Recent heart attack or have severe heart problems.
- •Previous treatment with Doxorubicin or certain other anticancer medications.
- •Allergy to certain other anti-cancer medicines, doxorubicin hydrochloride, Cis-platin, vincristine, paclitaxel, docetaxel, foscarnet, etc.
- •in the last 6 months.
- •Women with evidence of metastasis at the initial assessment.
- •Presence of clinical evidence for severe cardiac illness (angina pectoris, uncontrolled hypertension, arrhythmias, and left ventricular ejection fraction<50%).
- •Pregnant and breast-feeding women.
研究组 & 干预措施
Control Group
Control group received 4 cycles of the AC regimen (which consisted of an intravenous (IV) infusion of DOX (dose/cycle = 60 mg/m2) administered as a slow IV push over 5-10 min, followed by an infusion of cyclophosphamide (dose/cycle = 600 mg/m2) over 30-60 min, with a 21-day interval).
干预措施: AC protocol (Drug)
Motelukast Group
Motelukast Group will receive motelukast 10 mg daily for 4 cycles of the same AC regimen.
干预措施: Montelukast (Drug)
结局指标
主要结局
pro-BNP
时间窗: 6 months
serum concentration of the pro-BNP (ng/dl)
NF-KB
时间窗: 6 months
serum concentration of the NF-KB (ng/dl)
次要结局
未报告次要终点
研究者
Rehab Werida
Associate Professor
Damanhour University