Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapy-induced Cardiotoxicity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Grape Polyphenol Concentrate | Dietary Supplement | — | UNRESOLVED |
| Placebo (Dark Grape Juice) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Grape Polyphenol Concentrate
- description
- 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.
- interventionNames
- Dietary Supplement: Grape Polyphenol Concentrate
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 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.
- interventionNames
- Other: Placebo (Dark Grape Juice)
Primary outcomes (4)
- measure
- Change in High-Sensitivity Troponin Levels
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
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