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Search / Trial NCT06622954

Dietary Restriction to Prevent Cardiotoxicity in Breast Cancer Patients

Launched by ERASMUS MEDICAL CENTER · Sep 30, 2024

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Dietary Restriction Diet Anthracyclines High Sensitivity Troponin T Hs Tn T Oxidative Stress Breast Cancer Cardiotoxicity

ClinConnect Summary

This clinical trial is looking at how a special diet may help prevent heart problems in women with early breast cancer who are receiving a specific type of chemotherapy called anthracycline. The researchers want to see if a short-term diet that reduces calories by 30% and increases protein intake can make a difference in heart health, as measured by a blood test that checks for a certain protein related to heart damage.

To join the study, participants need to be women aged 18 to 75 who have recently been diagnosed with triple negative breast cancer and are about to start chemotherapy. They should have a body mass index (BMI) of at least 19 and must not have any serious heart issues or allergies to the diet's ingredients. Participants will be divided into two groups: one will follow the special diet while the other will continue with their regular eating habits. The trial is currently recruiting, and taking part may help researchers find better ways to protect heart health during cancer treatment.

Gender

FEMALE

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

About Erasmus Medical Center

Erasmus Medical Center, located in Rotterdam, Netherlands, is a leading academic medical center renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent institution within the Erasmus University Rotterdam, the center integrates cutting-edge scientific inquiry with comprehensive patient care, focusing on a wide range of medical specialties. With a strong emphasis on multidisciplinary collaboration, Erasmus Medical Center aims to translate research findings into tangible clinical applications, enhancing treatment options and improving patient outcomes. The institution is dedicated to conducting ethical and rigorous clinical trials that contribute to the global body of medical knowledge and foster advancements in personalized medicine.

Locations

Rotterdam, South Holland, Netherlands

Patients applied

0 patients applied

Trial Officials

Franny Jongbloed, MD/PhD

Principal Investigator

Erasmus Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported