Study Evaluating High-Fiber Diet and Short-Term Fasting to Support Immunotherapy in Adults with Melanoma

What this Trial Is About

Researchers are studying adults with stage IIB to IIIC melanoma who are receiving immunotherapy with checkpoint inhibitors. The study aims to explore whether combining a high-fiber diet with short-term fasting can support the effectiveness and tolerability of this cancer treatment. This research seeks to understand if dietary changes can improve treatment outcomes and reduce side effects. Participants will follow a high-fiber diet based on the German Nutrition Societys recommendations for at least 6 months. Half of the participants will also practice short-term fasting for 72 hours with each immunotherapy cycle, consuming up to 400 kcal per day. Another group will follow the high-fiber diet alone, and a control group will not receive dietary interventions. During the study, participants adherence to the diet and fasting, quality of life, fatigue, therapy tolerability, immune system status, and gut bacteria will be monitored. Various tests including blood counts, liver enzymes, and protein markers will be performed at baseline and regular intervals up to 18 months. The study will also track hospitalizations, treatment adjustments, and overall health over time.

Clinical Study on High-fiber Diet and Short-term Fasting in Melanoma Under Immunotherapy With Checkpoint Inhibition