Grape Polyphenols for Prevention of Chemotherapy-Induced Cardiotoxicity

N/ANot Yet RecruitingNCT07419711

Nazarbayev University120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

120

Conditions

Chemotherapy-induced Cardiotoxicity Breast Cancer

Interventions

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 0-3. * 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. Exclusion Criteria: * ECOG performance status of 4. * 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.

Outcomes

Primary Outcomes

Change in High-Sensitivity Troponin Levels

Change from baseline in serum high-sensitivity cardiac troponin levels as a marker of myocardial injury.

Time frame: Baseline, 3 months, and 6 months

Change in NT-proBNP Levels

Change from baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels as a marker of cardiac stress.

Time frame: Baseline, 3 months, and 6 months

Change in Left Ventricular Ejection Fraction (LVEF)

Change from baseline in left ventricular ejection fraction measured by transthoracic echocardiography.

Time frame: Baseline, 3 months, and 6 months

Change in Global Longitudinal Strain (GLS)

Change from baseline in left ventricular global longitudinal strain assessed by speckle-tracking echocardiography.

Time frame: Baseline, 3 months, and 6 months

Secondary Outcomes

Safety and Tolerability of Grape Polyphenol Supplementation

Incidence and severity of adverse events related to the grape polyphenol concentrate and placebo during the intervention period.

Time frame: Up to 3 months

Grape Polyphenols for Prevention of Chemotherapy-Induced Cardiotoxicity

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts