Grape Polyphenols for Prevention of Chemotherapy-Induced Cardiotoxicity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Grape Polyphenol Concentrate, Placebo (Dark Grape Juice).
- Who it may be relevant to
- Registry conditions: Chemotherapy-induced Cardiotoxicity, Breast Cancer. Basic parameters: 30 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cardioprotective Effects of Grape Polyphenols to Reduce Chemotherapy-Induced Cardiotoxicity in Breast Cancer Patients: A Randomized Pilot Study
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.
Interventions
- Dietary supplement Grape Polyphenol Concentrate
Grape polyphenol concentrate, 20 mg/mL; participants take 15 mL orally once daily for 3 months starting with chemotherapy. - Other Placebo (Dark Grape Juice)
Placebo (dark grape juice); participants take 15 mL orally once daily for 3 months starting with chemotherapy.
Primary outcome measures
- Change in High-Sensitivity Troponin Levels [Time frame: Baseline, 3 months, and 6 months]
- Change in NT-proBNP Levels [Time frame: Baseline, 3 months, and 6 months]
- Change in Left Ventricular Ejection Fraction (LVEF) [Time frame: Baseline, 3 months, and 6 months]
- Change in Global Longitudinal Strain (GLS) [Time frame: Baseline, 3 months, and 6 months]
Secondary outcome measures (1)
- Safety and Tolerability of Grape Polyphenol Supplementation [Time frame: Up to 3 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07419711 · AP26195341