Breast Cancer, Chemotherapy-induced Cardiotoxicity
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTGrape Polyphenol Concentrate
Grape polyphenol concentrate, 20 mg/mL; participants take 15 mL orally once daily for 3 months starting with chemotherapy.
OTHERPlacebo (Dark Grape Juice)
Placebo (dark grape juice); participants take 15 mL orally once daily for 3 months starting with chemotherapy.
Sponsors
Nazarbayev University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in High-Sensitivity Troponin Levels | Baseline, 3 months, and 6 months | Change from baseline in serum high-sensitivity cardiac troponin levels as a marker of myocardial injury. |
| Change in NT-proBNP Levels | Baseline, 3 months, and 6 months | Change from baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels as a marker of cardiac stress. |
| Change in Left Ventricular Ejection Fraction (LVEF) | Baseline, 3 months, and 6 months | Change from baseline in left ventricular ejection fraction measured by transthoracic echocardiography. |
| Change in Global Longitudinal Strain (GLS) | Baseline, 3 months, and 6 months | Change from baseline in left ventricular global longitudinal strain assessed by speckle-tracking echocardiography. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of Grape Polyphenol Supplementation | Up to 3 months | Incidence and severity of adverse events related to the grape polyphenol concentrate and placebo during the intervention period. |
Contacts
CONTACTMohamad Aljofan, PhD
Outcome results
None listed