Dietary Restriction to Prevent Cardiotoxicity in Breast Cancer Patients

Last updated: September 30, 2024
Sponsor: Erasmus Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

Protein- and Calorie restriction

Clinical Study ID

NCT06622954
MEC-2022-0823
  • Ages 18-75
  • Female

Study 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

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

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/orbiobank studies excluded);

  • Pregnant women

  • Previous treatment with anthracycline

  • Estrogen receptor positive status

Study Design

Total Participants: 32
Treatment Group(s): 1
Primary Treatment: Protein- and Calorie restriction
Phase:
Study Start date:
May 10, 2023
Estimated Completion Date:
May 31, 2026

Connect with a study center

  • Erasmus MC

    Rotterdam, South-Holland 3015 GD
    Netherlands

    Active - Recruiting

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