Online mind-body program to support a high-fiber diet during neoadjuvant immunotherapy for triple-negative breast cancer
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
NA · Kliniken Essen-Mitte · NCT07311083
This project will test whether an online group program with mind-body training helps women with triple-negative breast cancer switch to and tolerate a high-fiber diet while they receive neoadjuvant immunotherapy and chemotherapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Kliniken Essen-Mitte (other) |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Essen, North Rhine-Westphalia) |
| Trial ID | NCT07311083 on ClinicalTrials.gov |
What this trial studies
This randomized feasibility study compares an online integrative oncology group program (combining a high-fiber dietary concept with mind-body medicine elements) to standard care (a flyer and an educational video based on German Nutrition Society recommendations) in women with non-metastatic triple-negative breast cancer receiving neoadjuvant immunotherapy and chemotherapy. The intervention aims to support dietary change and tolerability, and the study will track recruitment, consent to randomization, dropout rates, implementation of dietary changes and acceptance of mind-body elements, and completeness of data. The rationale is based on evidence that a high-fiber, gut-healthy diet can modulate the microbiome and may influence immunotherapy and chemotherapy response and toxicity. If feasibility is demonstrated, a larger confirmatory trial will be planned to test effects on pathologic complete response (pCR).
Who should consider this trial
Good fit: Women aged 18–75 with histologically confirmed non-metastatic (stage I–III) triple-negative breast cancer who are scheduled for neoadjuvant chemotherapy plus immunotherapy and can participate in online German-language group sessions are ideal candidates.
Not a fit: Patients with metastatic disease, major gastrointestinal surgery (e.g., colectomy), specific food intolerances (fructose, histamine, gluten), incompatible diets (ketogenic), active substance abuse, severe psychiatric conditions preventing participation, or unwillingness to refrain from probiotics are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the approach could make it easier for patients to adopt a gut-healthy high-fiber diet that might improve treatment tolerability and enhance response to immunotherapy and chemotherapy.
How similar studies have performed: Prior research links the gut microbiome and dietary fiber to immunotherapy outcomes, but this specific online integrative high-fiber intervention in TNBC during neoadjuvant immunotherapy is largely untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Essen, North Rhine-Westphalia
- Evang. Kliniken Essen-Mitte gGmbH — Essen, North Rhine-Westphalia, Germany (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Microbiome