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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Protein- and Calorie restriction
Other interventionThe 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.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Protein- and Calorie restriction groupOther 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
High-sensitivity troponin T (hsTnT)
Cardiotoxicity as determined by the difference in concentrations of high-sensitivity troponin T (hsTnT) levels after protein and calorie restriction and anthracycline treatment in one cycle, delta HsTnT (Δ 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 outcomes
1
Left ventricular ejection fraction and global longitudinal (LVEF and GLS)
Echocardiography assessment of LVEF and GLS, to evaluate the overall effect on markers of cardiotoxicity and cardiac function.
Time frame
6 months and 12 months after start of anthracycline therapy2
Creatine kinase
Increase in creatine kinase after each cycle
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.3
Effect of dietary intervention on tumor volume/response
Radiographic response rate (measured as Complete Response / Partial Response / Stable Disease / Progression of disease, via RECIST method.
Time frame
After chemotherapy cycle 3 or cycle 4 (chemotherapy is given every 2 weeks)4
Metabolic parameters
Retinol binding protein, albumin and lipid profile.
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.Sponsors and contacts
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Source ClinicalTrials.gov