NCT06622954 Dietary Restriction to Prevent Cardiotoxicity in Breast Cancer Patients
| NCT ID | NCT06622954 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erasmus Medical Center |
| Condition | Cardiotoxicity |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2023-05-10 |
| Primary Completion | 2025-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 32 participants in total. It began in 2023-05-10 with a primary completion date of 2025-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to compare a dietary intervention with a regular diet in patients with early breast cancer undergoing anthracycline based chemotherapy. The main question it aims to answer is: What are the effects of a short-term diet with 30% caloric and 70% protein restriction (PCR) on cardiotoxicity induced by anthracycline treatment in women with newly diagnosed invasive breast cancer. Researchers will compare the control group with dietary intervention group to see if cardiotoxicity -measured by concentrations of high-sensitivity troponin T (hsTnT) levels- will be different between these two groups.
Eligibility Criteria
Inclusion Criteria: * women with newly diagnosed triple negative breast cancer with an indication for (neo-)adjuvant ATC-based chemotherapy and of intent to start anticancer treatment; * age between 18 and 75 years; * written informed consent; * body mass index ≥ 19. Exclusion Criteria: * Allergic to any of the ingredients of the diet; * Known history of cardiac dysfunction; * Severe morbidity with the inability to receive anticancer treatment. * Participation in another clinical trial with an intervention arm (database and/or biobank studies excluded); * Pregnant women * Previous treatment with anthracycline * Estrogen receptor positive status
Contact & Investigator
Franny Jongbloed, MD/PhD
PRINCIPAL INVESTIGATOR
Erasmus Medical Center
Frequently Asked Questions
Who can join the NCT06622954 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Cardiotoxicity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06622954 currently recruiting?
Yes, NCT06622954 is actively recruiting participants. Contact the research team at s.ditta@erasmusmc.nl for enrollment information.
Where is the NCT06622954 trial being conducted?
This trial is being conducted at Rotterdam, Netherlands.
Who is sponsoring the NCT06622954 clinical trial?
NCT06622954 is sponsored by Erasmus Medical Center. The principal investigator is Franny Jongbloed, MD/PhD at Erasmus Medical Center. The trial plans to enroll 32 participants.