CardiotoxicityPROTECT-CORNCT06622954
Dietary Restriction to Prevent Cardiotoxicity in Breast Cancer Patients
A study testing Protein- and Calorie restriction in people with Cardiotoxicity and Breast Cancer, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Cardiotoxicity, Breast Cancer
- What is being tested?
- Protein- and Calorie restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 May 2023to May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Franny Jongbloed, MD/PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus MC
Rotterdam, South Holland, 3015 GD
Sheraz Ditta, PharmD, +31639462883
Franny Jongbloed, MD/PhD, f.jongbloed@erasmusmc.nl
About this study
Official title: Protein and Calorie Restriction as Treatment for Prevention of Cardiotoxicity in Women Receiving Chemotherapy.
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.
- Conditions
- Cardiotoxicity, Breast Cancer
- Being tested
- Protein- and Calorie restriction
- Keywords
- Dietary restriction, Diet, Anthracyclines, High sensitivity troponin T, HsTnT, Oxidative stress, Breast cancer, Cardiotoxicity
- Medical subject headings
- Cardiotoxicity, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein- and Calorie restrictionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Protein- and Calorie restriction group | Other | This group will receive the dietary intervention. Receives: Other: Protein- and Calorie restriction |
| Control Group | No intervention | This group will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 (9)
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.
Measured: 6 months and 12 months after start of anthracycline therapy
Creatine kinase
Increase in creatine kinase after each cycle
Measured: 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.
Measured: After chemotherapy cycle 3 or cycle 4 (chemotherapy is given every 2 weeks)
Metabolic parameters
Retinol binding protein, albumin and lipid profile.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start10 May 2023
- Primary completionMay 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiotoxicityStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups, 1 control group and 1 intervention group.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franny Jongbloed, Erasmus Medical Center
- Investigators
- Franny Jongbloed, MD/PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622954
- Sponsor's protocol ID
- MEC-2022-0823
- Acronym
- PROTECT-COR
- Status last verified
- Sep 2024
- First submitted
- 6 Sep 2023
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein and Calorie Restriction as Treatment for Prevention of Cardiotoxicity in Women Receiving Chemotherapy.
- ClinicalTrials.gov ID
- NCT06622954
- Acronym / sponsor ID
- PROTECT-COR / MEC-2022-0823
- Conditions
- Cardiotoxicity, Breast Cancer
- Keywords
- Dietary restriction, Diet, Anthracyclines, High sensitivity troponin T, HsTnT, Oxidative stress, Breast cancer, Cardiotoxicity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups, 1 control group and 1 intervention group.
| Arm | Type | Receives |
|---|---|---|
| Protein- and Calorie restriction group | Other | Other: Protein- and Calorie restrictionThis group will receive the dietary intervention. |
| Control Group | No intervention | –This group will not receive any intervention. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein- and Calorie restrictionThe 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. | Other | Protein- and Calorie restriction group |
Primary outcome
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.
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).
9 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franny Jongbloed, MD/PhD contact
Franny Jongbloed, MD/PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein- and Calorie restriction in people with Cardiotoxicity and Breast Cancer, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheraz Ditta, PharmD (+31639462883, s.ditta@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.