NCT03451799

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Jethro Hu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• GBM
• Glioblastoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-04-13
• Primary completion: 2021-09-03
• Completion: 2024-04-29
• First posted: 2018-03-02
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States