|

Dietary Restriction to Prevent Cardiotoxicity in Breast Cancer Patients

RECRUITINGN/ASponsored by Erasmus Medical Center
Actively Recruiting
PhaseN/A
SponsorErasmus Medical Center
Started2023-05-10
Est. completion2025-05
Eligibility
Age18 Years – 75 Years
SexFEMALE
Healthy vol.Accepted

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

Age: 18 Years – 75 YearsSex: FEMALEHealthy volunteers accepted
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

Conditions4

Breast CancerCancerCardiotoxicityHeart Disease

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.