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Ketogenic Diet With Radiation and Chemotherapy for Newly Diagnosed Glioblastoma

NCT02046187 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2021-06-16

No results posted yet for this study

Summary

This study aims to see if reducing blood sugar and increasing ketones (a metabolic product that comes from using fats for energy) can increase survival and enhance the the effects of standard radiation and chemotherapy treatments used to treat glioblastoma multiforme (GBM). These changes occur from use of a ketogenic diet. This research has 2 goals:

1. Show that patients can tolerate the diet and maintain low blood glucose and high blood ketone levels.
2. Show if this diet enhances the effectiveness of standard treatment by prolonging survival of patients with a GBM.

Conditions

  • Glioblastoma (GBM)

Interventions

DIETARY_SUPPLEMENT

Ketogenic Diet

Patients/families meet with the study dietician after surgery to discuss the ketogenic diet (KD), ask questions and plan clinic visits. Before radiation and chemotherapy begins, training takes place about the diet, meal planning and ketone/glucose monitoring. Ketosis will begin with the help of the dietitian one week before radiation begins. The patient will follow a classic 4/1 KD during chemo-radiation, followed by a modified Atkins diet during monthly chemotherapy. At the end of this period patients will follow a normal low carbohydrate diet similar to a Diabetic diet. The dietitian will follow the patient over the course of treatment. The patient will take and record ketone and glucose blood levels daily from start to end of treatment MRI scan, and meet with the dietitian weekly during radiation, at follow-up visits and on an as-needed basis.

RADIATION

Radiation therapy

Patients receive standard dose (60Gy/30 fractions) external beam radiation

DRUG

Temozolomide

patients receive standard dose (75 mg/kg/day) temozolomide by mouth daily with radiation for 6 weeks. patients will also have standard maintenance dose (150-200 mg/kg/day) for five days each month for 12 cycles following radiation course.

Sponsors & Collaborators

  • St. Joseph's Hospital and Medical Center, Phoenix

    lead OTHER

Principal Investigators

  • Adrienne C Scheck, PhD · Barrow Neurological Research

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02046187 on ClinicalTrials.gov