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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grape Polyphenol Concentrate | Dietary Supplement | Grape polyphenol concentrate, 20 mg/mL; participants take 15 mL orally once daily for 3 months starting with chemotherapy. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of Grape Polyphenol Supplementation | Incidence and severity of adverse events related to the grape polyphenol concentrate and placebo during the intervention period. | Up to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamad Aljofan, PhD | Contact | +77054448869 | mohamad.aljofan@nu.edu.kz |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Placebo (Dark Grape Juice) | Other | Placebo (dark grape juice); participants take 15 mL orally once daily for 3 months starting with chemotherapy. |
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| D017437 |
| Skin and Connective Tissue Diseases |