Grape Polyphenols for Prevention of Chemotherapy-Induced Cardiotoxicity

Cardioprotective Effects of Grape Polyphenols to Reduce Chemotherapy-Induced Cardiotoxicity in Breast Cancer Patients: A Randomized Pilot Study

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 Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; Chemotherapy-induced Cardiotoxicity
• Intervention / Treatment: Dietary supplement: Grape Polyphenol Concentrate; Other: Placebo (Dark Grape Juice)

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamad Aljofan, PhD; Phone Number: +77054448869; Email: mohamad.aljofan@nu.edu.kz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Grape Polyphenol Concentrate; Grape polyphenol concentrate, 20 mg/mL; participants take 15 mL orally once daily for 3 months starting with chemotherapy.
Placebo Comparator: 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.	Other: Placebo (Dark Grape Juice); Placebo (dark grape juice); participants take 15 mL orally once daily for 3 months starting with chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in High-Sensitivity Troponin Levels	Change from baseline in serum high-sensitivity cardiac troponin levels as a marker of myocardial injury.	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.	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.	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.	Baseline, 3 months, and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 3 months

Collaborators and Investigators

• Sponsor: Nazarbayev University

Study record dates

Study Major Dates

• Study Start (Estimated): February 9, 2026
• Primary Completion (Estimated): May 9, 2026
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: February 6, 2026
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: AP26195341

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No