Lifestyle Program Supporting a High-Fiber Diet in Women Ages 18 to 75 With Triple-negative Breast Cancer Undergoing Neoadjuvant Immunotherapy and Chemotherapy

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.

Feasibility of a Lifestyle Intervention for Women With Triple-negative Breast Cancer Under Neoadjuvant Immunotherapy