At a glance
ClinicalIndex Comparison Record- ✓Adults 18 years or older
- ✓Newly diagnosed glioblastoma within 2 months of initial diagnosis by histopathology
- ✓Not started standard of care chemotherapy and/or radiation therapy for glioblastoma
- ✓Karnofsky Performance Status (KPS) ≥ 70
- ✕Recurrent glioblastoma
- ✕Genetic disorders affecting lipid metabolism (pyruvate carboxylase deficiency, porphyria, primary carnitine deficiency, carnitine palmitoyltransferase deficiency, carnitine translocase deficiency, beta-oxidation defects)
- ✕Inability to wean steroids below 8mg dexamethasone per day or equivalent
- ✕Body Mass Index (BMI) < 21 kg/m² unless investigator deems safe
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Controlled Phase 2 Study of the Ketogenic Diet Versus Standard Dietary Guidance for Patients With Newly Diagnosed Glioblastoma in Combination With Standard-of-care Treatment
In Brief
A Phase 2 clinical trial evaluating Keto Diet and Standard Anti-Cancer Diet for Glioblastoma Multiforme. Currently recruiting, targeting 170 participants across 5 sites.
Signals
Detailed Summary
This is a Phase 2, randomized two-armed, multi-site study of 170 patients with newly diagnosed glioblastoma multiforme. Patients will be randomized 1:1 to receive Keto Diet, or Standard Anti-Cancer Diet. All patients will receive standard of care treatment for their glioblastoma. The Keto Diet intervention will be for an 18-week period and conducted by trained research dietitians. Daily ketone and glucose levels will be recorded to monitor Keto Diet adherence. This two-armed randomized multi-site study aims to provide evidence to support the hypothesis that a Keto Diet vs. Standard Anti-Cancer Diet improves overall survival in newly diagnosed glioblastoma multiforme patients who receive standard of care treatment.
Study Details
Timeline
Interventions
The experimental intervention includes a strict and controlled diet that manages daily macronutrient breakdown and increases the ratio of dietary fat relative to protein and carbohydrate consumption.
Dietitian sessions will utilize the American Institute for Cancer Research Food resources and will reference foods low in fats such as fruits, vegetables and whole grains, providing key micronutrients and phytonutrients. Sessions will also focus on dietary support to help decrease any treatment related symptoms.