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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Michigan State University
Sponsor:
Collaborator:
Sparrow Health System
Information provided by (Responsible Party):
Kenneth Schwartz, MD, Michigan State University
ClinicalTrials.gov Identifier:
NCT01535911
First received: February 3, 2012
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

This study will look at the effects, good and/or bad, of treating primary brain cancers with diet therapy using a calorie restricted ketogenic diet that uses either Ketocal or food. A calorie restricted ketogenic diet is a diet designed to keep blood sugars in the low range of normal while at the same time increasing the blood concentration of metabolic break down products called ketones. This diet is currently used to treat children with uncontrollable seizures. This diet is well tolerated by the children with minimal side effects reported after using the diet for years.

  • The main purpose of this study is to find out whether or not the calorie restricted ketogenic diet will help patients with primary brain cancer by either decreasing the size of the cancer or by keeping the cancer from growing.
  • Another reason for doing this study is to learn about the side effects associated with the calorie restricted ketogenic diet in patients with primary brain cancer.

Condition Intervention Phase
Glioblastoma
Dietary Supplement: Energy restricted Ketogenic Diet (ERKD) (Metabolic Nutritional Therapy)
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of a Metabolic Nutritional Therapy for the Management of Primary Brain Tumors

Resource links provided by NLM:


Further study details as provided by Michigan State University:

Primary Outcome Measures:
  • A CT-PET scan will be used to measure changes in brain tumor size. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 12
Study Start Date: April 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Energy restricted Ketogenic Diet (ERKD) (Metabolic Nutritional Therapy)
    Twelve adult subjects with reoccurring glioblastoma will be referred to the study. Residual tumor size and baseline glucose uptake will be determined by 18fluoro-deoxyglucose (18FDG) PET/CT. Subjects will then be placed on ERKD for 6 weeks using Ketogenic diet. After 6 weeks of ERKD, tumor size and tumor glucose uptake will be determined by 18FDG PET/CT. 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. After completing 12 weeks of therapy with ERKD, patients will be reevaluated with 18FDG PET/CT. The inability of tumors to metabolize ketones is expected to prevent or slow tumor growth as evidenced by 18FDG PET/CT.
    Other Name: Ketogenic diet
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535911

Contacts
Contact: Kenneth Schwartz, MD 517-975-9547

Locations
United States, Michigan
Michigan State University/Sparrow Hospital Recruiting
E. Lansing, Michigan, United States, 48824
Contact: Ken A. Schwartz, MD    517-353-4811    ken.schwartz@hc.msu.edu   
Contact: Mary M. Noel, PhD    517.884.0451    mary.noel@hc.msu.edu   
Principal Investigator: Ken A Schwartz, MD         
Sponsors and Collaborators
Michigan State University
Sparrow Health System
Investigators
Principal Investigator: Kenneth Schwartz, MD Michigan State University
  More Information

Publications:
Responsible Party: Kenneth Schwartz, MD, Professor, Michigan State University
ClinicalTrials.gov Identifier: NCT01535911     History of Changes
Other Study ID Numbers: 11-452FS
Study First Received: February 3, 2012
Last Updated: November 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Michigan State University:
ketogenic diet
brain tumors

Additional relevant MeSH terms:
Brain Neoplasms
Glioblastoma
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on August 21, 2014