Phase 2 Randomized Study Comparing Ketogenic and Standard Anti-Cancer Diets in Adults With Newly Diagnosed Glioblastoma Receiving Standard Treatment

What this Trial Is About

Researchers are evaluating the effects of the Ketogenic Diet compared to the Standard Anti-Cancer Diet in patients with newly diagnosed glioblastoma multiforme. This Phase 2 randomized study aims to see if the Keto Diet can improve overall survival when combined with standard of care treatment. The trial involves 170 patients across multiple sites and seeks to provide evidence supporting dietary approaches in glioblastoma management. Participants will be randomly assigned to one of two groups. One group will follow an intensive 18-week Keto Diet managed by trained research dietitians, focusing on a strict macronutrient breakdown to increase dietary fat relative to protein and carbohydrates, with daily ketone and glucose monitoring to track adherence. The other group will receive Standard Anti-Cancer Diet guidance emphasizing foods low in fat, including fruits, vegetables, and whole grains, with dietitian support to help manage treatment-related symptoms. All patients will continue to receive standard chemotherapy and radiation treatments as part of their care. During the study, participants will be closely monitored through regular assessments that include overall survival tracked from baseline to 18 months, health-related quality of life, cognitive performance, and physical activity measured from baseline to 18 weeks. Daily ketone and glucose levels will be recorded for those on the Keto Diet. The study will also involve standard medical imaging and other evaluations as part of routine care. Participants will be involved in dietitian sessions and follow-up visits throughout the intervention period, with safety and health outcomes carefully assessed.

A Phase 2 Study of the Ketogenic Diet vs Standard Anti-cancer Diet Guidance for Patients With Glioblastoma in Combination With Standard-of-care Treatment