Actively Recruiting
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
Led by Kliniken Essen-Mitte · Updated on 2026-05-08
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
K
Kliniken Essen-Mitte
Lead Sponsor
K
Karl and Veronica Carstens Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Triple-negative breast cancer (TNBC) is a type of tumor with a high risk of recurrence and spread, requiring strong treatment that combines immunotherapy and chemotherapy. Researchers are investigating whether a high-fiber, gut-healthy diet can improve the response to these treatments and reduce side effects by influencing the microbiome. This study focuses on women with TNBC undergoing neoadjuvant immunotherapy and chemotherapy and aims to test the feasibility of supporting a high-fiber diet through an online integrative oncology group training program with mind-body elements compared to standard nutritional advice. Participants are randomly assigned to one of two groups. One group receives multi-professional support including consultations, individual counseling, and group sessions that combine mind-body medicine with nutritional therapy to help switch to a high-fiber diet of 20-30 grams daily. The control group receives standard care consisting of a leaflet and an educational video with dietary recommendations based on German Nutrition Society guidelines. The study period includes the time from enrollment through 6.5 months of treatment. During the study, participants complete questionnaires on quality of life, fatigue, fiber intake, and tolerance of increased fiber, along with stool samples to analyze fatty acid profiles and microbiome diversity at baseline and after six months. Body weight and therapy side effects are monitored regularly. The main measure is the feasibility of the intervention, with outcomes such as pathological complete remission and treatment toxicity also assessed. The study lasts about 6.5 months, aiming to see if this integrative approach can be successfully implemented and guide future research.
CONDITIONS
Brief Title
Feasibility of a Lifestyle Intervention for Women With Triple-negative Breast Cancer Under Neoadjuvant Immunotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 75 years
- Histologically confirmed diagnosis of non-metastatic triple-negative breast cancer (TNM stage I-III)
- Planned neoadjuvant chemotherapy and immunotherapy
- Willingness to participate and signed informed consent form
You will not qualify if you...
- Advanced disease stage with metastases
- Severe physical or psychiatric conditions preventing study participation
- Pregnancy
- Participation in other clinical studies involving behavioral, psychological, or complementary interventions
- Diet incompatible with a high-fiber diet (e.g., ketogenic diet)
- Drug or alcohol abuse
- Inability to complete questionnaires independently
- History of colectomy
- Gastrointestinal stenosis
- Fructose intolerance
- Histamine intolerance
- Gluten intolerance
- Unwillingness to avoid probiotics during the study
- Eating disorders
- No access to a laptop and/or camera for online group training
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6.5 months
Participants receive support to switch to a high-fibre diet combined with neoadjuvant immunotherapy and chemotherapy, or receive official dietary recommendations with educational materials. This includes multi-professional consultation hours, individual counselling, and group sessions with mind-body medicine and nutritional therapy, or standard care via a leaflet and video.
Multiple visits during 6.5 months including baseline and follow-up assessments
Trial Site Locations
Total: 1 location
1
Evang. Kliniken Essen-Mitte gGmbH
Essen, North Rhine-Westphalia, Germany, 45276
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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