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
Parallel
switching to a high-fibre diet
Other interventionThe aim of the intervention is to support patients in implementing a high-fibre diet (20-30 g of fibre per day) before and during systemic therapy. A multi-professional team consisting of a specialist doctor, a qualified nutritionist and an MBM therapist ensures comprehensive support during lifestyle modification. While the nutritional counselling provides recommendations for optimising diet, the MBM intervention addresses behavioural factors such as motivation, self-efficacy expectations and dealing with barriers to action. In addition, the specialist provides advice on symptom management.
official dietary recommendations
Other interventionproviding official dietary recommendations and an educational training video based on these recommendations of the guidelines of the German Nutrition Society (DGE)
The primary target parameter is the feasibility of the planned study and the intervention.
The feasibility criteria are defined in the following categories: Recruitment: * Recruitment is considered feasible if the required sample size of n = 60 patients can be recruited within 17 months. * Randomisation: Randomisation is considered feasible if at least 25% of potentially eligible patients agree to participate in the study * Dropout rate: A maximum dropout rate of 20% per group is considered proof of feasibility. * Intervention: The intervention is considered feasible if at least 80% of the patients who complete the study are able to implement the nutritional intervention according to protocol. Implementation according to protocol is defined as a fibre intake of at least 20 g/day and the consumption of fermented foods. Data collection: Data collection is considered feasible if complete data on the planned primary endpoint parameter of the planned confirmatory study, pCR, is available for at least 80% of the patients who complete the study.
Course of therapy (pCR)
Course of therapy in the sense of a complete response to systmatic therapy (= complete pathological remission)
Toxicity (CTCAE 6.0) including adverse events (AEs)
adverse events
Fatty acid profile (stool sample analysis)
Fatty acid profile
α-diversity and β-diversity of the microbiome (stool sample analysis)
diversity of the microbiome
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Kliniken Essen-Mitte
Lead sponsor
Karl and Veronica Carstens Foundation
Collaborator
