Chemotherapy-induced CardiotoxicityNCT07419711
Grape Polyphenols for Prevention of Chemotherapy-Induced Cardiotoxicity
A study testing Grape Polyphenol Concentrate in people with Chemotherapy-induced Cardiotoxicity and Breast Cancer, run by Nazarbayev University.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years, women only
- Conditions the study is for
- Chemotherapy-induced Cardiotoxicity, Breast Cancer
- What is being tested?
- Grape Polyphenol Concentrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 9 Feb 2026to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Cardioprotective Effects of Grape Polyphenols to Reduce Chemotherapy-Induced Cardiotoxicity in Breast Cancer Patients: A Randomized Pilot Study
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.
- Conditions
- Chemotherapy-induced Cardiotoxicity, Breast Cancer
- Being tested
- Grape Polyphenol Concentrate, Placebo (Dark Grape Juice)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grape Polyphenol ConcentrateDietary 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
Placebo (dark grape juice); participants take 15 mL orally once daily for 3 months starting with chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Grape Polyphenol Concentrate |
| 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. Receives: Other: Placebo (Dark Grape Juice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in High-Sensitivity Troponin Levels
Change from baseline in serum high-sensitivity cardiac troponin levels as a marker of myocardial injury.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start9 Feb 2026 (estimated)
- Primary completion9 May 2026 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced CardiotoxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nazarbayev University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419711
- Sponsor's protocol ID
- AP26195341
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardioprotective Effects of Grape Polyphenols to Reduce Chemotherapy-Induced Cardiotoxicity in Breast Cancer Patients: A Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT07419711
- Acronym / sponsor ID
- AP26195341
- Conditions
- Chemotherapy-induced Cardiotoxicity, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nazarbayev UniversityUniversity, hospital or other
- Study start
- 9 Feb 2026 (estimated)
- Primary completion
- 9 May 2026 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grape Polyphenol Concentrate | Experimental | Dietary Supplement: Grape Polyphenol ConcentrateParticipants 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. |
| Placebo | Placebo comparator | Other: Placebo (Dark Grape Juice)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. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grape Polyphenol ConcentrateGrape polyphenol concentrate, 20 mg/mL; participants take 15 mL orally once daily for 3 months starting with chemotherapy. | Dietary supplement | Grape Polyphenol Concentrate |
| Placebo (Dark Grape Juice)Placebo (dark grape juice); participants take 15 mL orally once daily for 3 months starting with chemotherapy. | Other | Placebo |
Primary outcome
Change in High-Sensitivity Troponin Levels
Time frame: 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
Time frame: 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)
Time frame: Baseline, 3 months, and 6 months
Change from baseline in left ventricular ejection fraction measured by transthoracic echocardiography.
Change in Global Longitudinal Strain (GLS)
Time frame: Baseline, 3 months, and 6 months
Change from baseline in left ventricular global longitudinal strain assessed by speckle-tracking echocardiography.
1 secondary outcome
Safety and Tolerability of Grape Polyphenol Supplementation
Time frame: Up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Grape Polyphenol Concentrate in people with Chemotherapy-induced Cardiotoxicity and Breast Cancer, run by Nazarbayev University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamad Aljofan, PhD (+77054448869, mohamad.aljofan@nu.edu.kz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in High-Sensitivity Troponin Levels (time frame: Baseline, 3 months, and 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.