Protein and calorie restriction as treatment for prevention of cardiotoxicity in women receiving chemotherapy.
- Conditions
- breast cancerMammacarcinoma10006291
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 32
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
1. Women with newly diagnosed triple negative or hormone receptor-positive
breast cancer with an indication for (neo-)adjuvant anthracycline-based
chemotherapy and of intent to start anticancer treatment
2. Age between 18 and 75 years
3. Written informed consent
4. Body mass index >= 19.
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
1. Allergic to any of the ingredients of the diet
2. Known history of cardiac dysfunction
3. Severe morbidity with the inability to receive anticancer treatment.
4. Participation in another clinical trial with an intervention arm (database
and/or biobank studies excluded)
5. Pregnant women
6. Previous treatment with anthracycline
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome measure is to investigate the effectiveness of a diet with<br /><br>30% caloric and 70% protein restriction on cardiotoxicity due to treatment with<br /><br>anthracyclines. The primary study variable is cardiotoxicity, as measured by<br /><br>high-sensitivity troponin T (hsTnT) concentrations.</p><br>
- Secondary Outcome Measures
Name Time Method