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ACTIVE NOT RECRUITING
NCT03451799
PHASE1

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

Sponsor: Jethro Hu

View on ClinicalTrials.gov

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.

Official title: IIT2016-17-HU-KETORADTMZ: A Phase 1 Study of a 4-month Ketogenic Diet in Combination With Standard-of-care Radiation and Temozolomide for Patients With Newly/Recently Diagnosed Glioblastoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

21

Start Date

2018-04-13

Completion Date

2026-05

Last Updated

2025-10-06

Healthy Volunteers

No

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.

Locations (1)

Cedars Sinai Medical Center

Los Angeles, California, United States