Grape Polyphenols for Prevention of Chemotherapy-Induced Cardiotoxicity
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
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
Treatments tested in this trial
- Grape Polyphenol Concentrate
- Placebo (Dark Grape Juice)
Treatment groups
120 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov