Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Erasmus MC
Rotterdam, South Holland, Netherlands, 3015 GD
Actively Recruiting
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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