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

NCT01535911 | Active Not Recruiting DMC

• 1 other identifier: 11-452FS
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma

Keywords

ketogenic diet; brain tumors

Outcome Measures

Primary Outcomes (1)

• MRI imaging will be used to measure changes in brain tumor size.

  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.

  6 weeks after completion of radiation therapy

Study Arms (1)

Obsrvational study adding ketogenic diet to standard initial treatment of glioblastom multiforme

EXPERIMENTAL

Add ketogenic diet to standard tx of glioblastoma multiforme. After patients have recovered from surgical intervention patients are given a ketogenic diet along with standard of care, radiation and temozolomide treatments. The ketogenic diet is modified by dietitians based on twice daily measurements of blood ketone levels.

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

Interventions

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

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.

Also known as: Ketogenic diet

Obsrvational study adding ketogenic diet to standard initial treatment of glioblastom multiforme

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Michigan State University: lead
• Sparrow Health System: collaborator

Study Sites (1)

Michigan State University/Sparrow Hospital

East Lansing, Michigan, 48824, United States

Location

Related Publications (2)

• Seyfried TN, Marsh J, Shelton LM, Huysentruyt LC, Mukherjee P. Is the restricted ketogenic diet a viable alternative to the standard of care for managing malignant brain cancer? Epilepsy Res. 2012 Jul;100(3):310-26. doi: 10.1016/j.eplepsyres.2011.06.017. Epub 2011 Aug 31.

  PMID: 21885251 BACKGROUND

• Schwartz K, Chang HT, Nikolai M, Pernicone J, Rhee S, Olson K, Kurniali PC, Hord NG, Noel M. Treatment of glioma patients with ketogenic diets: report of two cases treated with an IRB-approved energy-restricted ketogenic diet protocol and review of the literature. Cancer Metab. 2015 Mar 25;3:3. doi: 10.1186/s40170-015-0129-1. eCollection 2015.

  PMID: 25806103 DERIVED

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Kenneth Schwartz, MD

  Michigan State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 3, 2012
• First Posted: February 20, 2012
• Study Start: April 1, 2012
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

US (1)