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NCT Number: NCT06622954

Dietary Restriction to Prevent Cardiotoxicity in Breast Cancer Patients

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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Key information

Conditions

Cardiotoxicity Breast Cancer Breast Diseases Breast Neoplasms Cardiovascular Diseases Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Heart Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Erasmus MC

Rotterdam, South Holland, 3015 GD, Netherlands

Location status: Recruiting

Location contact

Franny Jongbloed, MD/PhD

CONTACT

[email protected]

Sheraz Ditta, PharmD

CONTACT

+31639462883

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Franny Jongbloed, MD/PhD

CONTACT

[email protected]

Sheraz Ditta, PharmD

CONTACT

[email protected]

+31639462883

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

Protein and Calorie Restriction as Treatment for Prevention of Cardiotoxicity in Women Receiving Chemotherapy.

Acronym: PROTECT-COR

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 2, 2024
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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