An interventional study of Protein- and Calorie restriction in Cardiotoxicity and Breast Cancer, sponsored by Erasmus Medical Center. Status unknown at 1 site in Netherlands. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-10-02.
Sponsored by Erasmus Medical Center · Not applicable, Interventional, and Prevention
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.
269 studies on the registry are indexed under Cardiotoxicity; 71 are open to participants now.
This study's planned enrollment of 32 is below the median of 93 across 139 interventional studies indexed under Cardiotoxicity.
Browse Cardiotoxicity studies →Erasmus Medical Center is the lead sponsor of 478 studies on the registry; 183 are open to participants now.
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Exclusion Criteria:
This group will receive the dietary intervention.
Other: Protein- and Calorie restriction
This group will not receive any intervention.
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.
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.
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 therapy
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.
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)
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.
Other anthracycline-related toxicities
Measured with CTCAE grading, part of standard of care.
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
Effect of dietary intervention on pharmacokinetics of the anthracycline, as measured by concentrations of anthracycline after each chemotherapy cycle.
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
Difference in troponin levels, before and after each of the other chemotherapy cycles (that are not taken for primary outcome measure), 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.
Brain natriuretic peptide (NT-proBNP)
Increase in brain natriuretic peptide after each cycle
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
Subjective wellbeing will be measured using the following questionnaires: EuroQol, VAS-scores, multidimensional fatigue index.
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.
Started May 2023 (actual). Primary completion is estimated for May 2025, 24 months after the start.
Of 48 non-industry interventional studies with no phase under Cardiotoxicity, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 82. This study's planned 24 months is below that.
Counting every sponsor, half of 48 studies reached it within 59 months; a quarter within 37 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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