NCT07311083 Feasibility of a Lifestyle Intervention for Women With Triple-negative Breast Cancer Under Neoadjuvant Immunotherapy
| NCT ID | NCT07311083 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kliniken Essen-Mitte |
| Condition | Microbiome |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-02-01 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * A diet that is incompatible with a high-fiber diet, such as the ketogenic diet * Abuse of drugs and/or alcohol * Inability to complete the questionnaires independently * Colectomy * Gastrointestinal stenosis * Fructose intolerance * Histamine intolerance * Gluten intolerance * Ketogenic diet * Unwillingness to refrain from taking probiotics for the duration of the study * Eating disorders * No laptop and/or camera available to participate in the online group training program
Frequently Asked Questions
Who can join the NCT07311083 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Microbiome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07311083 currently recruiting?
Yes, NCT07311083 is actively recruiting participants. Visit ClinicalTrials.gov or contact Kliniken Essen-Mitte to inquire about joining.
Where is the NCT07311083 trial being conducted?
This trial is being conducted at Essen, Germany.
Who is sponsoring the NCT07311083 clinical trial?
NCT07311083 is sponsored by Kliniken Essen-Mitte. The trial plans to enroll 60 participants.