Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07419711

Grape Polyphenols for Prevention of Chemotherapy-Induced Cardiotoxicity

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Chemotherapy-induced Cardiotoxicity Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

30 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Grape Polyphenol Concentrate

Dietary Supplement

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

Placebo (Dark Grape Juice)

Other

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

Primary outcomes

  1. Change in High-Sensitivity Troponin Levels

    Time frame: Baseline, 3 months, and 6 months

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

  2. Change in NT-proBNP Levels

    Time frame: 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.

  3. Change in Left Ventricular Ejection Fraction (LVEF)

    Time frame: Baseline, 3 months, and 6 months

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

  4. Change in Global Longitudinal Strain (GLS)

    Time frame: Baseline, 3 months, and 6 months

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

Secondary outcomes

  1. Safety and Tolerability of Grape Polyphenol Supplementation

    Time frame: Up to 3 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamad Aljofan, PhD

CONTACT

[email protected]

+77054448869

Sponsors and collaborators

Lead sponsor

Nazarbayev University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.