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

NCT03451799 | Completed Phase 1 DMC

• 1 other identifier: IIT2016-17-HU-KETORADTMZ
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

GBM; Glioblastoma

Keywords

Glioblastoma; Ketogenic diet; Keto diet; GBM

Outcome Measures

Primary Outcomes (2)

• 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.

  Four Months

• Safety of the intervention

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

  Four months

Secondary Outcomes (9)

• Feasibility of the intervention

  Four Months

• Overall Survival

  Sixty months

• Time-to-progression

  Four Months

• Quality of Life (two months)

  Two months

• Quality of Life (four months)

  Four months

Study Arms (1)

Ketogenic diet+radiation+temozolomide

EXPERIMENTAL

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

Ketogenic Diet OTHER

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.

Ketogenic diet+radiation+temozolomide

Standard-of-care radiation RADIATION

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

Ketogenic diet+radiation+temozolomide

Standard-of-care Temozolomide DRUG

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

Ketogenic diet+radiation+temozolomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Jethro Hu: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Jethro Hu, MD

  Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Faculty

Model Details: Single arm, prospective cohort

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 2, 2018
• Study Start: April 13, 2018
• Primary Completion: September 3, 2021
• Study Completion: April 29, 2024
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)