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Compares treatment options for Glioblastoma Multiforme
Official title 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
ClinicalTrials.gov ID: NCT05708352
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Patients with recurrent glioblastoma
- Genetic disorders that affect lipid metabolism. Including but not limited to pyruvate carboxylase deficiency, porphyria, primary carnitine...
- 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
See the full eligibility 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- San Francisco, California, United States
- Santa Monica, California, United States
- Durham, North Carolina, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; San Francisco, California, United States; Santa Monica, California, United States; Durham, North Carolina, United States; Milwaukee, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.