Triple-negative breast cancer (TNBC) is considered a tumor with a high risk of recurrence and metastasis and requires aggressive systemic therapy combining immunotherapy and chemotherapy. If the therapy leads to complete remission (pCR), this is prognostically beneficial for patients.
Studies demonstrating the influence of the microbiome on the development of cancer and on the efficacy and toxicity of immunotherapy and chemotherapy underscore the potential of targeted nutritional interventions. Current data from microbiome research indicate that a high-fiber, gut-healthy diet modulates the microbiota in such a way that the response to and toxicity of immunotherapy and chemotherapy could be improved.
The aim of this project is to translate these findings into clinical care. The study will investigate whether an online integrative oncology group training program with mind-body elements supports and is feasible for the implementation of a high-fiber diet in patients with TNBC undergoing neoadjuvant immunotherapy and chemotherapy. The program will be compared with a control group that receives a flyer with nutritional recommendations. If the feasibility of this complementary medicine approach can be demonstrated, a confirmatory study is planned to investigate the expected effect on the pathological complete remission of TNBC.
Female patients aged 18-75
Histologically confirmed diagnosis of non-metastatic triple-negative breast cancer (TNM stage I-III) with planned neoadjuvant chemotherapy and immunotherapy
Willingness to participate in the study and signed consent form
Advanced stage of disease with metastases
Severe physical or psychopharmacologically treated psychiatric comorbidity that prevents a patient from participating in the study
Pregnancy
Participation in other clinical studies involving behavioral, psychological, or complementary medical interventions
Kliniken Essen-Mitte
Lead sponsor
Karl and Veronica Carstens Foundation
Collaborator