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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

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment170 people
  • Recruiting US sites4
  • SponsorCedars-Sinai Medical Center
  • RegistryNCT05708352

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

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: a one-minute explainerNCT057083521 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to no maximum
  • SexAll
  • Healthy volunteersNo

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
  • Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

You cannot join if

  • 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

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

  • Keto Diet (Behavioral): 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.
  • Standard Anti-Cancer Diet (Behavioral): 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.

The study

Treatment groups

Randomized · Parallel · masking: None

Keto-Diet (Experimental)

Intensive 18-week Keto Diet intervention.

Standard Anti-Cancer Diet (Placebo Comparator)

Standard Anti-Cancer Diet with Dietitian support

Goals

What the study measures

Main goals

  • Overall survival (From Baseline to 18 Months)

Other goals

  • Health-related quality of life 1
  • Health-related quality of life 2
  • Progression-free survival
  • Cognitive performance 1
  • Cognitive performance 2
  • Physical activity
  • Physical activity

Planned enrollment: 170 (estimated).

Where

Recruiting US sites

  • Cedars-Sinai Medical Center, Los Angeles, California
  • University of California, San Francisco, San Francisco, California
  • Pacific Neuroscience Institute / Saint John's Cancer Institute, Santa Monica, California
  • Duke University, Durham, North Carolina

Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Aug 4, 2026. Public record; not medical advice.

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