Feasibility of a Lifestyle Intervention for Women With Triple-negative Breast Cancer Under Neoadj… (NCT07311083) | Clinical Trial Compass
RecruitingNot Applicable
Feasibility of a Lifestyle Intervention for Women With Triple-negative Breast Cancer Under Neoadjuvant Immunotherapy
Germany60 participantsStarted 2026-02-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary target parameter is the feasibility of the planned study and the intervention.
Timeframe: from the enrolment to the end of treatment at 6.5 months