Comparing a Ketogenic Diet to a Standard Anti-Cancer Diet for Glioblastoma Patients
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
This study is testing if a Ketogenic Diet can help people with newly diagnosed glioblastoma live longer compared to a standard anti-cancer diet while they receive their usual treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 5 sites (Los Angeles, California and 4 other locations) |
| Trial ID | NCT05708352 on ClinicalTrials.gov |
What this trial studies
This Phase 2 study involves 170 patients with newly diagnosed glioblastoma multiforme who will be randomly assigned to either a Ketogenic Diet or a Standard Anti-Cancer Diet while receiving standard treatment. The intervention will last for 18 weeks, with trained dietitians overseeing the dietary adherence and monitoring daily ketone and glucose levels. The goal is to determine if the Ketogenic Diet can improve overall survival compared to the standard diet in these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with newly diagnosed glioblastoma who have not yet started standard chemotherapy or radiation therapy.
Not a fit: Patients with recurrent glioblastoma or those with genetic disorders affecting lipid metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a dietary approach that enhances survival outcomes for glioblastoma patients.
How similar studies have performed: While the use of dietary interventions in cancer treatment is being explored, this specific comparison of a Ketogenic Diet against a Standard Anti-Cancer Diet in glioblastoma is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Los Angeles, California and 4 other locations
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
- Pacific Neuroscience Institute / Saint John's Cancer Institute — Santa Monica, California, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Withdrawn)
Study contacts
- Principal investigator: Jethro Hu, MD — Cedars-Sinai Medical Center
- Study coordinator: Clinical Trial Recruitment Navigator
- Email: GroupCancerTrialInformation@cshs.org
- Phone: 3104232133
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.