Pilot Study of a Metabolic Nutritional Therapy for the Management of Primary Brain Tumors

NAActive, not recruitingINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

April 1, 2012

Primary Completion Date

June 1, 2026

Study Completion Date

June 1, 2026

Conditions
Glioblastoma
Interventions
OTHER

Energy restricted Ketogenic Diet (ERKD) (Metabolic Nutritional Therapy)

Adult subjects with newly diagnosed glioblastoma will be referred to the study. Residual tumor size will be determined using MRI imaging. Subjects will be placed on ERKD while they are being treated with radiation therapy and standard of care chemotherapy. After completion of radiation therapy, tumor size will be determined using MRI. If the tumor has decreased in size or remained the same (stable disease), the subjects will be continued on the ERKD for an additional 6 weeks. Total calories consumed by each subject will be targeted to 20 to 25 kcal/kg/day. If the tumor has decreased in size or the size has remained the same then subjects will be continued on the ERKD for as additional 6 weeks and a repeat MRI will be obtained.

Trial Locations (1)

48824

Michigan State University/Sparrow Hospital, East Lansing

All Listed Sponsors
collaborator

Sparrow Health System

OTHER

lead

Michigan State University

OTHER

NCT01535911 - Pilot Study of a Metabolic Nutritional Therapy for the Management of Primary Brain Tumors | Biotech Hunter | Biotech Hunter