Breast cancer/Mammacarcinoma
Conditions
Interventions
After consent has been given by the patients, they will be divided into 2  
groups:
1) The intervention group. This group follows a prescribed diet 5 days prior to 
each anthracycline based chemotherapy cycle, for a maximum of 4 cycles. This diet consists of 30% 
caloric and 70% protein restriction, based on the individual daily energy 
requirement.
2) The control group. This group is not prescribed a diet, but is called by a dietitian 
just before each anthracycline chemotherapy to ask what has been eaten in the 
past 24 hours. Based on this, the caloric and macronutrient intake is 
calculated.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Women with newly diagnosed triple negative or hormone receptor-positive breast cancer with an indication for (neo-)adjuvant anthracycline-based chemotherapy and of intent to start anticancer treatment 2. Age between 18 and 75 years 3. Written informed consent 4. Body mass index >= 19.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. Allergic to any of the ingredients of the diet 2. Known history of cardiac dysfunction 3. Severe morbidity with the inability to receive anticancer treatment. 4. Participation in another clinical trial with an intervention arm (database and/or biobank studies excluded) 5. Pregnant women 6. Previous treatment with anthracycline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is to investigate the effectiveness of a diet with 30% caloric and 70% protein restriction on cardiotoxicity due to treatment with anthracyclines. The primary study variable is cardiotoxicity, as measured by high-sensitivity troponin T (hsTnT) concentrations. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures are: - Difference in troponin levels, before and after each chemotherapy cycle, ? HsTnT.- Brain natriuretic peptide, creatine kinase, electrocardiograms and ultrasounds of the left ventricular ejection fraction (LVEF) and global longitudinal strain (GLS).- Other anthracycline-related toxicity, which will be measured by CTCAE-grading.- Pharmacokinetics of anthracycline chemotherapy, following dietary restriction. This is measured as concentrations of anthracyclines and the active metabolites. - Well-being of patients after dietary restriction and chemotherapy, to be measured by means of questionnaires. - Metabolic parameters to assess dietary adherence: retinol binding protein, albumin, insulin and lipid profile. - Effects of dietary restriction on tumor progression and tumor size by radiographic response before, during and after treatment. This is presented as Complete Response / Partial Response / Stable Disease / Progression of disease, using the RECIST method. This response is also used as standard of care and has therefore already been validated. | — |
Countries
Netherlands
Contacts
Public ContactSA Ditta
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed