Dietary Restriction to Prevent Cardiotoxicity in Breast Cancer Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorErasmus Medical Center
About this trial
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
Qualifiers
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.
Disqualifiers
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);
Trial design
Treatments tested in this trial
- Protein- and Calorie restriction
Treatment groups
32 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov