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Trial Title:
Dietary Restriction to Prevent Cardiotoxicity in Breast Cancer Patients
NCT ID:
NCT06622954
Condition:
Cardiotoxicity
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Cardiotoxicity
Conditions: Keywords:
Dietary restriction
Diet
Anthracyclines
High sensitivity troponin T
HsTnT
Oxidative stress
Breast cancer
Cardiotoxicity
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Two groups, 1 control group and 1 intervention group.
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Protein- and Calorie restriction
Description:
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.
Arm group label:
Protein- and Calorie restriction group
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Erasmus MC
Address:
City:
Rotterdam
Zip:
3015 GD
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Sheraz Ditta, PharmD
Phone:
+31639462883
Contact backup:
Last name:
Franny Jongbloed, MD/PhD
Email:
f.jongbloed@erasmusmc.nl
Start date:
May 10, 2023
Completion date:
May 2026
Lead sponsor:
Agency:
Erasmus Medical Center
Agency class:
Other
Source:
Erasmus Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06622954
