Grape Polyphenols for Prevention of Chemotherapy-Induced Cardiotoxicity

NCT07419711 | Not Yet Recruiting

• 1 other identifier: AP26195341
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chemotherapy-induced Cardiotoxicity; Breast Cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Safety and Tolerability of Grape Polyphenol Supplementation

  Up to 3 months

Study Arms (2)

Grape Polyphenol Concentrate

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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)

Interventions

Grape Polyphenol Concentrate DIETARY_SUPPLEMENT

Grape polyphenol concentrate, 20 mg/mL; participants take 15 mL orally once daily for 3 months starting with chemotherapy.

Grape Polyphenol Concentrate

Placebo (Dark Grape Juice) OTHER

Placebo (dark grape juice); participants take 15 mL orally once daily for 3 months starting with chemotherapy.

Placebo

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nazarbayev University: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Mohamad Aljofan, PhD

CONTACT

+77054448869; mohamad.aljofan@nu.edu.kz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 19, 2026
• Study Start: February 9, 2026
• Primary Completion (Estimated): May 9, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share