Protein and Calorie Restriction as Treatment for Prevention of Cardiotoxicity in Women Receiving Chemotherapy

What this Trial Is About

Researchers are evaluating the effects of a short-term diet with 30% calorie and 70% protein restriction on heart damage caused by anthracycline chemotherapy in women with newly diagnosed invasive breast cancer. The study compares this dietary intervention to a regular diet to see if the diet can reduce cardiotoxicity, measured by high-sensitivity troponin T (hsTnT) levels. This trial is sponsored by Erasmus Medical Center and focuses on early breast cancer patients undergoing anthracycline-based chemotherapy. Participants are randomly assigned to one of two groups: one group receives a dietary intervention using Scandishake from Nutricia tailored to reduce calories and protein, while the control group follows their usual diet without intervention. The chemotherapy cycles are given every two weeks for a total of four cycles. Blood samples and other measurements are taken before and one hour after each chemotherapy cycle to monitor heart-related effects and other health indicators. During the study, participants will have blood tests to measure hsTnT, creatine kinase, metabolic markers, and heart function tests such as left ventricular ejection fraction and global longitudinal strain at six and twelve months after starting chemotherapy. Researchers will also assess tumor response, other chemotherapy-related side effects, and participants' wellbeing through questionnaires during and after the treatment period. The study aims to observe these effects over the course of the chemotherapy and up to one year afterward.

Dietary Restriction to Prevent Cardiotoxicity in Breast Cancer Patients