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

Phase 0
18 Years
90 Years
Open (Enrolling)

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Trial Information

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

Summary: The current standard of care for glioblastoma multiforme (GBM), the most common
primary brain tumor in adults, includes surgical resection, radiation and chemotherapy.
Survival rarely exceeds 18 months. The investigators propose to test the hypothesis that
brain tumor cells are unable to utilize ketones as a source of energy when deprived of
glucose, due to mitochondrial dysfunction, whereas normal glia and neurons can survive this
metabolic stress. A nutritionally adequate but energy restricted, ketogenic diet (ERKD) to
deprive brain tumors of energy and resulting in death of glioma cells is promising.
ERKD-based therapy to manage brain cancer is both biologically plausible and supported by
data in animal models. A multidisciplinary team of oncologists, registered dietitians, and
physiologists will implement an ERKD therapy in two (2) GBM subjects for an 8 week, phase 1
clinical trial. After receiving standard medical care for GBM including biopsy or tumor
excision, ERKD therapy will be initiated for subjects during a one week inpatient admission
to Sparrow Hospital and supervised by registered dietitians experienced in implementing this
therapy. The objective of this trial is to determine whether the ERKD causes altered glucose
metabolism in gliomas and decreases tumor size in individuals with GBM as measured by
positron emission tomography/ computed tomography in the Department of Radiology at MSU.
Enzymes and signaling pathways that regulate metabolism and cell growth will be assessed in
initial and post-ERKD tumors using standard biochemical approaches.


Inclusion Criteria:

- Adult subjects over age 18 with biopsy proven GBM diagnosis

- Measurable disease after standard therapies

- Eastern Cancer Oncology Group performance status < or =2; and

- Life expectancy >3 months.

Exclusion Criteria:

- Diagnosis of diabetes mellitus that is being treated by medication

- Concomitant use of glucocorticosteroids

- Cholecystectomy within 1 year prior to study entry

- Symptoms requiring immediate surgical intervention or radiation therapy

- Inability to adhere to or tolerate dietary protocol

- Active malignancy other than primary brain tumor requiring therapy

- Participation in an investigational study within 2 weeks prior to study entry; Major
co-morbidities such as liver, kidney or heart failure that in the judgment of the
investigators would disqualify the subject from the trial

- Pregnancy

- Inability to give informed consent

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

A CT-PET scan will be used to measure changes in brain tumor size.

Outcome Description:

Results of the metabolic therapy will be assessed by comparing CT-PET scans obtained at the beginning of the study with those after 6 and 12 weeks of metabolic therapy.

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator

Kenneth Schwartz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Michigan State University


United States: Institutional Review Board

Study ID:




Start Date:

April 2012

Completion Date:

November 2015

Related Keywords:

  • Glioblastoma
  • ketogenic diet
  • brain tumors
  • Brain Neoplasms
  • Glioblastoma



Michigan State University/Sparrow Hospital E. Lansing, Michigan  48824