Grape Polyphenols for Prevention of Chemotherapy-Induced Cardiotoxicity (NCT07419711) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Grape Polyphenols for Prevention of Chemotherapy-Induced Cardiotoxicity
120 participantsStarted 2026-02-09
Plain-language 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.
Who can participate
Age range
30 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in High-Sensitivity Troponin Levels
Timeframe: Baseline, 3 months, and 6 months
2
Change in NT-proBNP Levels
Timeframe: Baseline, 3 months, and 6 months
3
Change in Left Ventricular Ejection Fraction (LVEF)