Breast Cancer, Cardiotoxicity
Conditions
Keywords
Dietary restriction, Diet, Anthracyclines, High sensitivity troponin T, HsTnT, Oxidative stress, Breast cancer, Cardiotoxicity
Brief 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.
Interventions
OTHERProtein- 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.
Sponsors
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Two groups, 1 control group and 1 intervention group.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| High-sensitivity troponin T (hsTnT) | 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. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Creatine kinase | 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. | Increase in creatine kinase after each cycle |
| Effect of dietary intervention on tumor volume/response | After chemotherapy cycle 3 or cycle 4 (chemotherapy is given every 2 weeks) | Radiographic response rate (measured as Complete Response / Partial Response / Stable Disease / Progression of disease, via RECIST method. |
| Metabolic parameters | 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. | Retinol binding protein, albumin and lipid profile. |
| Other anthracycline-related toxicities | After each anthracycline based chemotherapy cycle, which is given every 2 weeks. There will be 4 cycles in total. | Measured with CTCAE grading, part of standard of care. |
| Left ventricular ejection fraction and global longitudinal (LVEF and GLS) | 6 months and 12 months after start of anthracycline therapy | Echocardiography assessment of LVEF and GLS, to evaluate the overall effect on markers of cardiotoxicity and cardiac function. |
| Troponin levels | 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. | Difference in troponin levels, before and after each of the other chemotherapy cycles (that are not taken for primary outcome measure), Δ HsTnT. |
| Brain natriuretic peptide (NT-proBNP) | 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. | Increase in brain natriuretic peptide after each cycle |
| Subjective wellbeing | 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. | Subjective wellbeing will be measured using the following questionnaires: EuroQol, VAS-scores, multidimensional fatigue index. |
| Effect of dietary intervention on pharmacokinetics of anthracycline | 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. | Effect of dietary intervention on pharmacokinetics of the anthracycline, as measured by concentrations of anthracycline after each chemotherapy cycle. |
Countries
Netherlands
Contacts
Primary ContactSheraz Ditta, PharmD
Backup ContactFranny Jongbloed, MD/PhD
Outcome results
None listed