Dietary Restriction to Prevent Cardiotoxicity in Breast Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Protein- and Calorie restriction.
- Who it may be relevant to
- Registry conditions: Cardiotoxicity, Breast Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Protein and Calorie Restriction as Treatment for Prevention of Cardiotoxicity in Women Receiving Chemotherapy.
Overview
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.
Interventions
- Other Protein- and Calorie restriction
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.
Primary outcome measures
- High-sensitivity troponin T (hsTnT) [Time frame: Bloodsamples will be taken before and 1 hour after each anthracycline based chemotherapy cycle. The cycles are given once every 2 weeks, for 4 cycles in total.]
Secondary outcome measures (9)
- Left ventricular ejection fraction and global longitudinal (LVEF and GLS) [Time frame: 6 months and 12 months after start of anthracycline therapy]
- Creatine kinase [Time frame: Bloodsamples will be taken before and 1 hour after each anthracycline cycle. The cycles are given once every 2 weeks, for 4 cycles in total.]
- Effect of dietary intervention on tumor volume/response [Time frame: After chemotherapy cycle 3 or cycle 4 (chemotherapy is given every 2 weeks)]
- Metabolic parameters [Time frame: Bloodsamples will be taken before and 1 hour after each anthracycline based chemotherapy cycle. The cycles are given once every 2 weeks, for 4 cycles in total.]
- Other anthracycline-related toxicities [Time frame: After each anthracycline based chemotherapy cycle, which is given every 2 weeks. There will be 4 cycles in total.]
- Effect of dietary intervention on pharmacokinetics of anthracycline [Time frame: Bloodsamples will be taken before and 1 hours after each anthracycline based chemotherapy cycle. The cycles are given once every 2 weeks, for 4 cycles in total.]
- Troponin levels [Time frame: Bloodsamples will be taken before and 1 hour after each anthracycline based chemotherapy cycle. The cycles are given once every 2 weeks, for 4 cycles.]
- Brain natriuretic peptide (NT-proBNP) [Time frame: Bloodsamples will be taken before and 1 hour after each anthracycline based chemotherapy cycle. The cycles are given once every 2 weeks, for 4 cycles in total.]
- Subjective wellbeing [Time frame: During each anthracycline chemotherapy cycle. The chemotherapy is given every 2 weeks, in total 4 cycles. Then 6 months and 12 months after start of anthracycline therapy questionnaires will be taken again.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Netherlands · 1 center
- Erasmus MC — Rotterdam
Identifiers
NCT: NCT06622954 · MEC-2022-0823