Cardioprotective Effects of Grape Polyphenols to Reduce Chemotherapy-Induced Cardiotoxicity in Breast Cancer Patients: A Randomized Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Change in NT-proBNP Levels
研究概览
简要总结
This pilot randomized clinical study aims to evaluate the cardioprotective effects of a grape polyphenol concentrate in patients receiving anthracycline- and/or trastuzumab-based chemotherapy. Adult patients at high or very high risk of chemotherapy-induced cardiotoxicity will be randomized to receive either a grape polyphenol concentrate or placebo for three months, starting with chemotherapy. Cardiac function and cardiotoxicity will be assessed using echocardiographic parameters and circulating biomarkers at baseline, 3 months, and 6 months.
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 30 to 75 years.
- •Histologically confirmed breast cancer.
- •Planned treatment with anthracycline- and/or trastuzumab-based chemotherapy.
- •High or very high risk of chemotherapy-induced cardiotoxicity (≥20%), based on clinical assessment.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Ability to take oral study products.
- •Willingness to comply with study procedures and follow-up visits.
- •Written informed consent provided prior to any study procedures.
排除标准
- •ECOG performance status of
- •Pre-existing severe cardiovascular disease that would interfere with study participation.
- •Permanent atrial fibrillation or other clinically significant arrhythmias.
- •Severe hepatic or renal impairment.
- •Active central nervous system tumors or metastases.
- •Uncontrolled arterial hypertension.
- •Acute gastrointestinal diseases that may impair absorption.
- •Known allergy or intolerance to grape products or study components.
- •Participation in another interventional clinical trial that may interfere with the outcomes of this study.
研究组 & 干预措施
Grape Polyphenol Concentrate
Participants receive a grape polyphenol concentrate (QAYNAR) at a dose of 15 mL orally once daily for 3 months, starting with anthracycline- and/or trastuzumab-based chemotherapy.
干预措施: Grape Polyphenol Concentrate (Dietary Supplement)
Placebo
Participants receive placebo (dark grape juice) at a dose of 15 mL orally once daily for 3 months, starting with anthracycline- and/or trastuzumab-based chemotherapy.
干预措施: Placebo (Dark Grape Juice) (Other)
结局指标
主要结局
Change in NT-proBNP Levels
时间窗: Baseline, 3 months, and 6 months
Change from baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels as a marker of cardiac stress.
Change in High-Sensitivity Troponin Levels
时间窗: Baseline, 3 months, and 6 months
Change from baseline in serum high-sensitivity cardiac troponin levels as a marker of myocardial injury.
Change in Left Ventricular Ejection Fraction (LVEF)
时间窗: Baseline, 3 months, and 6 months
Change from baseline in left ventricular ejection fraction measured by transthoracic echocardiography.
Change in Global Longitudinal Strain (GLS)
时间窗: Baseline, 3 months, and 6 months
Change from baseline in left ventricular global longitudinal strain assessed by speckle-tracking echocardiography.
次要结局
- Safety and Tolerability of Grape Polyphenol Supplementation(Up to 3 months)