Dietary Restriction to Prevent Cardiotoxicity in Breast Cancer Patients (PROTECT-COR)

September 30, 2024 updated by: Franny Jongbloed, Erasmus Medical Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
    • South-Holland
      • Rotterdam, South-Holland, Netherlands, 3015 GD
        • Recruiting
        • Erasmus MC
        • Contact:
        • Contact:
          • Sheraz Ditta, PharmD
          • Phone Number: +31639462883

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
This group will not receive any intervention.
Other: Protein- and Calorie restriction group
This group will receive the dietary intervention.
Other: Protein- 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricular ejection fraction and global longitudinal (LVEF and GLS)
Time Frame: 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.
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.
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
Time Frame: 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.
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.
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
Time Frame: 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.
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.
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
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.
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)
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.
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
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Investigators

  • Principal Investigator: Franny Jongbloed, MD/PhD, Erasmus Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2023

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

September 6, 2023

First Submitted That Met QC Criteria

September 30, 2024

First Posted (Actual)

October 2, 2024

Study Record Updates

Last Update Posted (Actual)

October 2, 2024

Last Update Submitted That Met QC Criteria

September 30, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC-2022-0823

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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