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NCT Number: NCT05708352

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

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.

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Key information

Conditions

Glioblastoma Multiforme Astrocytoma Glioblastoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cedars-Sinai Medical Center, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Overall survival

    Time frame: 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 outcomes

  1. Health-related quality of life 1

    Time frame: 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.

  2. Health-related quality of life 2

    Time frame: 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.

  3. Progression-free survival

    Time frame: 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.

  4. Cognitive performance 1

    Time frame: 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.

  5. Cognitive performance 2

    Time frame: 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.

  6. Physical activity

    Time frame: 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.

  7. Physical activity

    Time frame: From Baseline to 18 Weeks

    Measured by Fitbit data changes. The higher the step count the better the physical activity.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trial Recruitment Navigator

CONTACT

[email protected]

3104232133

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Feb 1, 2023
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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