NCT07311083Recruiting
Feasibility of a Lifestyle Intervention for Women With Triple-negative Breast Cancer Under Neoadjuvant Immunotherapy
Feasibility of a Lifestyle Intervention to Switch to a High-fiber, Gut-healthy Diet in Women With Triple-negative Breast Cancer Undergoing Neoadjuvant Immunotherapy: a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 16 Dec 2025
- Start date
- 1 Feb 2026
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- Kliniken Essen-Mitte
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT07311083
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Feb 2026 to the primary completion date, 1 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Abuse of drugs and/or alcohol
Other illness
- Advanced stage of disease with metastases
- Severe physical or psychopharmacologically treated psychiatric comorbidity that prevents a patient from participating in the study
- Eating disorders
Other
- 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
- 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
- No laptop and/or camera available to participate in the online group training program
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Evang. Kliniken Essen-Mitte gGmbh Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.