Dietary Restriction to Prevent Cardiotoxicity in Breast Cancer Patients (PROTECT-COR)

Erasmus University

Status

Enrolling

Conditions

Cardiotoxicity

Breast Cancer

Treatments

Other: Protein- and Calorie restriction

Study type

Interventional

Funder types

Other

Identifiers

NCT06622954

MEC-2022-0823

Details and patient eligibility

About

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.

Enrollment

32 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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