Glioblastoma Multiforme
Conditions
Keywords
Keto Diet
Brief 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.
Interventions
BEHAVIORALKeto Diet
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.
BEHAVIORALStandard Anti-Cancer Diet
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.
Sponsors
National Cancer Institute (NCI)
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | From Baseline to 18 Months | Will be calculated as the number of days from the date of patient registration to the date of death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life 1 | From Baseline to 18 Weeks | 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. |
| Health-related quality of life 2 | From Baseline to 18 Weeks | 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. |
| Cognitive performance 1 | From Baseline to 18 Weeks | 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. |
| Cognitive performance 2 | From Baseline to 18 Weeks | Measured by changes in the Trail Marking Test A/B survey scores. The longer the task takes to complete the lower the cognitive performance. |
| Physical activity | From Baseline to 18 Weeks | Measured by changes in the modified Godin leisure questionnaire survey scores. The more minutes per week spent in exercise the better the physical activity. |
| Progression-free survival | From Baseline to 18 Weeks | 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. |
Countries
United States
Contacts
Primary ContactClinical Trial Recruitment Navigator
Outcome results
None listed