NCT07137793招募中2 期
Clinical Study to Evaluate The Cardioprotective Effect of Pentoxifylline Against Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- change in ejection fraction
研究概览
简要总结
The goal of this clinical trial is to evaluate the cardioprotective effect of pentoxifylline against doxorubicin-induced cardiotoxicity in breast cancer patients. The main questions it aims to answer are:
- What is the change in ejection fraction (primary outcome) in breast cancer patients receiving pentoxifylline compared to those who do not?
- What are the changes in serum levels of N-terminal pro-B-type natriuretic peptide (NT-pro-BNP), and TNF-α (secondary outcomes) in breast cancer patients receiving pentoxifylline compared to those who do not? Researcher will compare breast cancer patients receiving standard chemotherapy alone (Group one: Positive control group; n=23) to breast cancer patients receiving standard chemotherapy plus pentoxifylline (Group two: pentoxifylline group; n=23) to see if pentoxifylline mitigates the cardiac side effects associated with doxorubicin treatment.
Participants will:
Be randomized to receive either a chemotherapeutic regimen alone or with pentoxifylline.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years old.
- •Chemo-naïve patients with biopsy confirmed diagnosis of breast cancer and with stage I-III breast cancer according to the American Joint Committee on Cancer (TNM staging system of breast cancer).
- •Patients intended to receive at least 4 cycles of doxorubicin or more.
- •Patients with performance status <2 according to Eastern Cooperative Oncology Group (ECOG) score.
- •Echocardiographic LVEF ≥55%.
- •Adequate baseline hematologic values (absolute neutrophilic count ≥ 1.5 ×109/L, platelet count ≥ 90 × 109/L and hemoglobin level ≥ 10 g/dl).
- •Patients with adequate liver function and adequate renal function.
- •Signed informed consent to participate in the study.
排除标准
- •Age <18 years old and >65 years old.
- •Women with history of breast cancer.
- •Formerly treated with DOX.
- •Patients with a known hypersensitivity to any of the used drugs.
- •Treatment with blood thinners for 6 months prior to the screening.
- •Treatment with NSAIDS like ketorolac,ibuprofen.
- •Patients taking any other cardioprotective medications.
- •Pregnancy and breast feeding.
- •Alcohol abuse.
- •Creatine Clearance < 50 mL/min.
- •History of heart failure or LVEF <50%.
- •Presence of any cardiac-related conditions such as angina pectoris, valvular disease, uncontrolled systemic hypertension, coronary heart disease, and cardiac surgery within the last 3 months.
研究组 & 干预措施
Pentoxifylline 400mg plus chemotherapy
Active Comparator
干预措施: Pentoxifylline 400mg plus chemotherapy (Drug)
结局指标
主要结局
change in ejection fraction
时间窗: 3 MONTHS
次要结局
- changes in serum levels of the measured biological markers(3 MONTHS)
研究者
Sondos Mahmoud Elfeky
bachelor
Tanta University
研究点 (1)
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