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Dietary Restriction to Prevent Cardiotoxicity in Breast Cancer Patients

Dietary Restriction to Prevent Cardiotoxicity in Breast Cancer Patients

Recruiting
18-75 years
Female
Phase N/A

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Overview

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) levelswill be different between these two groups.

Eligibility

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

Study details
    Cardiotoxicity
    Breast Cancer

NCT06622954

Erasmus Medical Center

15 October 2025

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