Dietary Restriction to Prevent Cardiotoxicity in Breast Cancer Patients
Recruiting · NCT06622954 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Protein- and Calorie restriction
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.
Who can take part
Age range
18 Years to 75 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Erasmus MC - Rotterdam, South Holland, Netherlands