Dietary Restriction to Prevent Cardiotoxicity in Breast Cancer Patients
Protein and Calorie Restriction as Treatment for Prevention of Cardiotoxicity in Women Receiving Chemotherapy.
Erasmus Medical Center
32 participants
May 10, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria7
- 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
Interventions
The intervention consists of 30% calorie and 70% protein restriction, based on their daily nutritional intake. The protein and calorie restriction will be given in the form of Scandishake from Nutricia. These are ready available and easy to tailor to the caloric and protein need of each individual study subject.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06622954