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

NCT03451799 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-04-15

No results posted yet for this 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.

Conditions

Interventions

OTHER

Ketogenic 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.

RADIATION

Standard-of-care radiation

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

DRUG

Standard-of-care Temozolomide

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

Sponsors & Collaborators

  • Jethro Hu

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-13
Primary Completion
2021-09-03
Completion
2024-04-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03451799 on ClinicalTrials.gov