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CompletedNCT03451799Updated Apr 15, 2026

Ketogenic Diet in Combination With Standard-of-care Radiation and Temozolomide for Patients With Glioblastoma

A Phase 1 interventional study of Ketogenic Diet and Standard-of-care radiation in GBM and Glioblastoma, sponsored by Jethro Hu. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-15.

Sponsored by Jethro Hu · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
21
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Enrolled subjects will be placed on a 16-week ketogenic diet (subject specific as prescribed by RD) while receiving standard of care cancer treatment (Radiation + Temozolomide). Study dietitians will create personalized meal plans for each patient with the goal of achieving and maintaining protocol defined metabolic ketosis. Subjects will be monitored for safety, nutrition, quality of life, and standard of care tumor assessments over the course of the study.

Read the detailed description

Enrolled subjects will be placed on a 16-week ketogenic diet (subject specific as prescribed by RD) while receiving standard of care cancer treatment (Radiation + Temozolomide). Study dietitians will place patients on a strict and controlled diet that manages daily macronutrient breakdown and increases the ratio of dietary fat relative to protein and carbohydrate consumption. Dietitians will provide guidance and teaching of the diet, as well as, monitoring and diet adjustment to ensure metabolic ketosis. Dietitians and study physicians (and their staff) will monitor subjects for safety, nutrition, quality of life, and standard of care tumor assessments over the course of the study.

02

Conditions studied

  • GBM
  • Glioblastoma

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Keywords

  • Glioblastoma
  • Ketogenic diet
  • Keto diet
  • GBM
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adults (age ≥ 18 years)
  • Newly or recently diagnosed glioblastoma. Patients may enroll in the study from the time of diagnosis (prior to the initiation of standard-of-care chemoradiation) up until the initiation of post-radiation adjuvant chemotherapy (typically approximately 3-4 weeks after the completion of radiation therapy). Overall, this provides a window of approximately 3 months from the time of diagnosis for patients to enroll in this study. No recurrent glioblastoma is allowed on trial.
  • Being seen for treatment of glioblastoma at Cedars-Sinai Medical Center. Note: Okay if patients receiving chemotherapy or radiation therapy at another facility
  • Patients on low and managed doses of steroids are permitted. Up to 8 mg dexamethasone or steroid equivalent.

Exclusion criteria

Exclusion Criteria:

  • Karnofsky Performance Status of \<70 as deemed by physician or equivalent
  • Body Mass Index of \<22 kg/m2 (rounded to nearest integer)
  • Patients with disorders that affect lipid metabolism such as pyruvate carboxylase deficiency, porphyria, primary carnitine deficiency, carnitine palmitoyltransferase I or II deficiency, carnitine translocase deficiency, Beta-Oxidation Defects
  • Medical comorbidities that in the opinion of the investigator limits the patient's ability to complete this study
  • Pregnant, nursing, or implanted with an intrauterine device (IUD) that is not MR compatible
  • Patients who are vegan or vegetarian will be excluded, as the ketogenic diet includes foods that may interfere with these preferences
  • Patients on high doses of steroids will be excluded
  • Patients currently receiving experimental therapeutic therapy will be excluded from the trial. Note: Off-label therapy use is permitted
  • Inability to adhere to the protocol
  • Patients with history of allergic reactions to surgical steel or elastomer/rubber are excluded from the activity monitor portion of the study. Because the activity monitor uses a Bluetooth low energy Transceiver, individuals using pacemakers, implantable cardiac defibrillators, neuro-stimulation devices, cochlear implants, hearing aids, or other electronic medical equipment should also be excluded from wearing the activity monitor. They can still use the Aria scale to record weight.
  • Patients with mechanically, magnetically, or electrically activated implants, such as cardiac pacemakers, neurostimulators, and infusion pumps, that are not magnetic resonance imaging/positron emission tomography (MRI/PET) compatible.
  • Patients with ferromagnetic implants and ferromagnetic foreign bodies, such as intracranial, aneurysm clips, shrapnel and intraocular metal chips as these could become dislodged.
  • Patients unable to tolerate MRI/PET imaging secondary to an inability to lie supine or severe claustrophobia as assessed by the treating physician or principal investigator.
  • Patients unable to lie still, hold their breath, or follow imaging procedure instructions as assessed by the treating physician or PI.
  • Patients whose most recent renal function test does not meet Cedars-Sinai Medical center standard of care MRI contrast protocol requirements (glomerular filtration rate \<45ml/min).
  • Patients with a known allergy to Fludeoxyglucose F18 (F18-FDG) radioactive tracer or gadolinium-based contrast agent.
  • Patients with allergy to animal dander or animal-instigated asthma.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    Ketogenic diet+radiation+temozolomide

    Ketogenic diet in combination with standard-of-care radiation and standard-of-care temozolomide

    Other: Ketogenic Diet · Radiation: Standard-of-care radiation · Drug: Standard-of-care Temozolomide

Interventions

  • OtherKetogenic Diet

    A 4-month ketogenic diet will be supervised and monitored by the study investigators. Study dietitians will create personalized meal plans for each patient with the goal of achieving and maintaining metabolic ketosis.

  • RadiationStandard-of-care radiation

    Patients will receive standard-of-care radiation. Radiation is not protocol directed.

  • DrugStandard-of-care Temozolomide

    Patients will receive standard-of-care temozolomide. Temozolomide is not protocol directed.

05

What researchers measure

Primary outcomes

  1. Safety of the intervention

    Proportion of participants experiencing a 10% decrease in weight or body mass index AND have a BMI \<18.5 within one month from initiation of the ketogenic diet.

    Time frame: Four Months

  2. Safety of the intervention

    Number of related adverse events based on CTCAE v.5.

    Time frame: Four months

Secondary outcomes

  1. Feasibility of the intervention

    Proportion of enrolled patients able to maintain blood ketone levels \>0.3 mM for over 50% of days on study starting 2 weeks after initiation of the ketogenic diet.

    Time frame: Four Months

  2. Overall Survival

    Time (in months) from initiation of the ketogenic diet to date of death

    Time frame: Sixty months

  3. Time-to-progression

    Time (in months) from baseline to progressive disease over study duration (estimated 4 months) \- measured by RANO criteria (standard of care brain MRI)

    Time frame: Four Months

  4. Quality of Life (two months)

    Mean change in overall Quality of Life from baseline to two months. -Quality of Life measured using EORTC QLQ-C30 global score

    Time frame: Two months

  5. Quality of Life (four months)

    Mean change in overall Quality of Life from baseline to four months. -Quality of Life measured using EORTC QLQ-C30 global score

    Time frame: Four months

  6. Cognitive function (Hopkins Verbal Learning Test-Revised)

    Mean change in cognitive function from initiation of ketogenic diet to four months. -measured using Hopkins Verbal learning Test-Revised

    Time frame: Four months

  7. Cognitive function (Trail Making Test)

    Mean change in cognitive function from initiation of ketogenic diet to four months. -measured using Trail Making Test

    Time frame: Four months

  8. Cognitive function (Controlled Word Association Test)

    Mean change in cognitive function from initiation of ketogenic diet to four months. -measured using Controlled Word Association Test

    Time frame: Four months

  9. Cognitive function (Montreal Cognitive Assessment)

    Mean change in cognitive function from initiation of ketogenic diet to four months. -measured using Montreal Cognitive Assessment

    Time frame: Four months

06

Study locations

1 site
  • Cedars Sinai Medical Center
    Los Angeles, California 90048, United States
07

Registry details

Key details

Study ID
NCT03451799
Lead sponsor
Jethro Hu
Responsible party
Jethro Hu (Principal Investigator, Faculty, Cedars-Sinai Medical Center) — Sponsor-investigator
First posted
Mar 2, 2018
Start date
Apr 13, 2018
Primary completion
Sep 3, 2021
Completion
Apr 29, 2024
Last update
Apr 15, 2026

Study contacts

Jethro Hu, MD
principal investigator · Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
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