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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01535911
Recruitment Status : Active, not recruiting
First Posted : February 20, 2012
Last Update Posted : October 31, 2018
Sponsor:
Collaborator:
Sparrow Health System
Information provided by (Responsible Party):
Kenneth Schwartz, MD, Michigan State University

Tracking Information
First Submitted Date  ICMJE February 3, 2012
First Posted Date  ICMJE February 20, 2012
Last Update Posted Date October 31, 2018
Study Start Date  ICMJE April 2012
Estimated Primary Completion Date October 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2014)
MRI imaging will be used to measure changes in brain tumor size. [ Time Frame: 6 weeks after completion of radiation therapy ]
Results of the metabolic therapy will be assessed by comparing MRI images obtained at the beginning of the study with those after completion of radiation therapy and after an additional 6 weeks of metabolic therapy.
Original Primary Outcome Measures  ICMJE
 (submitted: February 15, 2012)
A CT-PET scan will be used to measure changes in brain tumor size. [ Time Frame: 12 weeks ]
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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study of a Metabolic Nutritional Therapy for the Management of Primary Brain Tumors
Official Title  ICMJE Pilot Study of a Metabolic Nutritional Therapy for the Management of Primary Brain Tumors
Brief Summary

This study will look at the effects, good and/or bad, of treating primary brain cancers with diet therapy using an energy restricted ketogenic diet (ERKD) that uses food. An energy 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 energy 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 energy restricted ketogenic diet in patients with primary brain cancer.
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 newly diagnosed GBM subjects. After initial maximal tumor excision, ERKD therapy will be initiated for subjects during a one week inpatient admission to Sparrow Hospital or as a local outpatient and supervised by registered dietitians experienced in implementing this therapy.The ERKD will continue as adjunctive therapy along with radiation therapy and standard of care chemotherapy. The supervised ERKD will continue for an additional 6 weeks after completion of radiation therapy along with the standard of care chemotherapy. The objective of this trial is to determine whether the ERKD decreases tumor size or results in no recurrence in individuals with GBM as measured by serial MRI imaging. Enzymes and signaling pathways that regulate metabolism and cell growth will be assessed in initial and post-ERKD tumors using standard biochemical approaches.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma
Intervention  ICMJE 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.
Other Name: Ketogenic diet
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 29, 2018)
16
Original Estimated Enrollment  ICMJE
 (submitted: February 15, 2012)
2
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date October 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01535911
Other Study ID Numbers  ICMJE 11-452FS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kenneth Schwartz, MD, Michigan State University
Study Sponsor  ICMJE Michigan State University
Collaborators  ICMJE Sparrow Health System
Investigators  ICMJE
Principal Investigator: Kenneth Schwartz, MD Michigan State University
PRS Account Michigan State University
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP