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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Protein- and Calorie restriction group | Other | This group will receive the dietary intervention. |
|
| Control Group | No Intervention | This group will not receive any intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protein- and Calorie restriction | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months and 12 months after start of anthracycline therapy |
| Creatine kinase |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheraz Ditta, PharmD | Contact | +31639462883 | s.ditta@erasmusmc.nl | |
| Franny Jongbloed, MD/PhD | Contact | f.jongbloed@erasmusmc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Franny Jongbloed, MD/PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus MC | Recruiting | Rotterdam | South Holland | 3015 GD | Netherlands |
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| ID | Term |
|---|---|
| D066126 | Cardiotoxicity |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011506 | Proteins |
| ID | Term |
|---|---|
| D000602 | Amino Acids, Peptides, and Proteins |
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Two groups, 1 control group and 1 intervention group.
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|
Increase in creatine kinase after each cycle |
| 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. | After chemotherapy cycle 3 or cycle 4 (chemotherapy is given every 2 weeks) |
| Metabolic parameters | Retinol binding protein, albumin and lipid profile. | 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. | 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. | 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. | 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 | 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. | 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. |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |