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Dietary Restriction to Prevent Cardiotoxicity in Breast Cancer Patients

NCT06622954 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-10-02

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Franny Jongbloed, MD/PhD · Erasmus Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-10
Primary Completion
2025-05-31
Completion
2026-05-31

Countries

  • Netherlands

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06622954 on ClinicalTrials.gov