Health TrialsbyHealthPanel

Grape Polyphenols for Prevention of Chemotherapy-Induced Cardiotoxicity

ConditionsChemotherapy-induced CardiotoxicityBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-75
SponsorNazarbayev University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Grape Polyphenol Concentrate

    Dietary supplement

    Grape polyphenol concentrate, 20 mg/mL; participants take 15 mL orally once daily for 3 months starting with chemotherapy.

  • Placebo (Dark Grape Juice)

    Other intervention

    Placebo (dark grape juice); participants take 15 mL orally once daily for 3 months starting with chemotherapy.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Grape Polyphenol ConcentrateExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nazarbayev University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: