Dietary Restriction to Prevent Cardiotoxicity in Breast Cancer Patients

NCT06622954 | Recruiting

• 1 other identifier: MEC-2022-0823
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Dietary restriction; Diet; Anthracyclines; High sensitivity troponin T; HsTnT; Oxidative stress; Breast cancer; Cardiotoxicity

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (9)

• Left ventricular ejection fraction and global longitudinal (LVEF and GLS)

  6 months and 12 months after start of anthracycline therapy

• Creatine kinase

  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

  After chemotherapy cycle 3 or cycle 4 (chemotherapy is given every 2 weeks)

• Metabolic parameters

  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

  After each anthracycline based chemotherapy cycle, which is given every 2 weeks. There will be 4 cycles in total.

Study Arms (2)

Protein- and Calorie restriction group

OTHER

This group will receive the dietary intervention.

Other: Protein- and Calorie restriction

Control Group

NO INTERVENTION

This group will not receive any intervention.

Interventions

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.

Protein- and Calorie restriction group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

MeSH Terms

Conditions

Cardiotoxicity; Breast Neoplasms

Interventions

Proteins

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Franny Jongbloed, MD/PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheraz Ditta, PharmD

CONTACT

+31639462883; s.ditta@erasmusmc.nl

Franny Jongbloed, MD/PhD

CONTACT

f.jongbloed@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two groups, 1 control group and 1 intervention group.

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: October 2, 2024
• Study Start: May 10, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: October 2, 2024

Record last verified: 2024-09

Locations

NL (1)