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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Glioblastoma Multiforme

Intervention / Treatment
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* Behavioral: Keto Diet
* Behavioral: Standard Anti-Cancer Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Ability to read, write and understand either English OR Spanish Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. Exclusion Criteria: Patients with recurrent glioblastoma Genetic disorders that affect lipid metabolism. Including but not limited to pyruvate carboxylase deficiency, porphyria, primary carnitine deficiency, carnitine palmitoyltransferase I or II deficiency, carnitine translocase deficiency, beta-oxidation defects Inability to wean steroids below 8mg dexamethasone / day or equivalent Body Mass Index (BMI) < 21kg/m2, unless the site Principal Investigator deems safe Currently pregnant or nursing Patients receiving other experimental therapy Note: Off-label therapy use is permitted Comorbidities that in the opinion of the investigator limit the patient's ability to complete the study Food preferences incompatible with keto diet Using a pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implants (removable hearing aids permitted), or other electronic medical equipment, unless the site Principal Investigator deems safe Inability to participant in standard of care MRIs

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Keto-Diet<br>Intensive 18-week Keto Diet intervention. | Behavioral: Keto Diet<br>* 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.<br>|
| Placebo Comparator: Standard Anti-Cancer Diet<br>Standard Anti-Cancer Diet with Dietitian support | Behavioral: Standard Anti-Cancer Diet<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Will be calculated as the number of days from the date of patient registration to the date of death. | From Baseline to 18 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life 1 | Measured by changes in the Functional Assessment of Cancer Therapy - Brain (FACT-BR) survey scores. Scores can range from 0- 200, the higher the score the better the quality of life. | From Baseline to 18 Weeks | 
| Health-related quality of life 2 | Measured by changes in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) survey scores. Scores can range from 0- 160, the higher the score the better the quality of life. | From Baseline to 18 Weeks | 
| Progression-free survival | Assessed with Magnetic resonance imaging (MRI) scan of the brain with and without gadolinium. MRI's will be reviewed and assessed for progression free survival via the modified Response Assessment in Neuro-Oncology Criteria. | From Baseline to 18 Weeks | 
| Cognitive performance 1 | Measured by changes in the Hopkins Verbal Test (HVLT-R) survey scores. Scores can range from 0-36, higher the scores the better the cognitive performance. | From Baseline to 18 Weeks | 
| Cognitive performance 2 | Measured by changes in the Trail Marking Test A/B survey scores. The longer the task takes to complete the lower the cognitive performance. | From Baseline to 18 Weeks | 
| Physical activity | Measured by changes in the modified Godin leisure questionnaire survey scores. The more minutes per week spent in exercise the better the physical activity. | From Baseline to 18 Weeks | 
| Physical activity | Measured by Fitbit data changes. The higher the step count the better the physical activity. | From Baseline to 18 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Keto Diet