An interventional study of Grape Polyphenol Concentrate and Placebo (Dark Grape Juice) in Chemotherapy-induced Cardiotoxicity and Breast Cancer, sponsored by Nazarbayev University. Not yet recruiting. Open to female participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-19.
Sponsored by Nazarbayev University · Not applicable, Interventional, and Prevention
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 120 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Nazarbayev University is the lead sponsor of 14 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Dietary Supplement: Grape Polyphenol Concentrate
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.
Other: Placebo (Dark Grape Juice)
Grape polyphenol concentrate, 20 mg/mL; participants take 15 mL orally once daily for 3 months starting with chemotherapy.
Placebo (dark grape juice); participants take 15 mL orally once daily for 3 months starting with chemotherapy.
Change in High-Sensitivity Troponin Levels
Change from baseline in serum high-sensitivity cardiac troponin levels as a marker of myocardial injury.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 3 months, and 6 months
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.
Time frame: Up to 3 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Nazarbayev University