Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
FEMALE
NCT06622954

Dietary Restriction to Prevent Cardiotoxicity in Breast Cancer Patients

Led by Erasmus Medical Center · Updated on 2024-10-02

32

Participants Needed

1

Research Sites

155 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Dietary Restriction to Prevent Cardiotoxicity in Breast Cancer Patients

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women with newly diagnosed triple negative breast cancer scheduled for (neo-)adjuvant anthracycline-based chemotherapy
  • Age between 18 and 75 years
  • Able to provide written informed consent
  • Body mass index (BMI) of 19 or higher
Not Eligible

You will not qualify if you...

  • Allergy to any ingredients of the diet
  • Known history of cardiac dysfunction
  • Severe illness preventing anticancer treatment
  • Participation in another clinical trial with an intervention arm (excluding database or biobank studies)
  • Pregnant women
  • Previous treatment with anthracycline chemotherapy
  • Estrogen receptor positive breast cancer status

AI-Screening

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Trial Site Locations

Total: 1 location

1

Erasmus MC

Rotterdam, South Holland, Netherlands, 3015 GD

Actively Recruiting

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Research Team

S

Sheraz Ditta, PharmD

CONTACT

F

Franny Jongbloed, MD/PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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