← Back to Search

Metabolic Nutritional Therapy

Ketogenic Diet for Brain Cancer (Ketones Trial)

Q: Are new participants still being incorporated into this experiment?

Unfortunately, the trial is not currently enrolling patients. Clinicaltrials.gov indicates that this particular study was posted on April 1st 2012 and last updated on April 28th 2022; however, there are still 796 other clinical studies actively seeking participants for their respective trials.

Q: Are elderly patients with this condition being included in the research?

According to the inclusion criteria, those eligible for this trial should be aged from 18-90. Alternatively, there are a total of 101 clinical trials available for minors and 725 suitable studies offered to seniors.

Q: Is it possible to enlist in this research endeavor?

This clinical trial is accepting individuals with <a href="https://www.withpower.com/clinical-trials/glioblastoma">glioblastoma</a>, aged 18 to 90. To be eligible for the study, potential participants must have a confirmed diagnosis of <a href="https://www.withpower.com/clinical-trials/gbm">GBM</a> and an Eastern <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> <a href="https://www.withpower.com/clinical-trials/oncology">Oncology</a> Group performance status less than or equal to 2; additionally they are required to possess a life expectancy greater than three months.

N/A

Waitlist Available

Led By Kenneth Schwartz, MD

Research Sponsored by Michigan State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult subjects over age 18 with biopsy proven GBM diagnosis

Eastern Cancer Oncology Group performance status < or =2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks after completion of radiation therapy

Awards & highlights

Ketones Trial Summary

This trial will test the effects of an energy restricted ketogenic diet on primary brain cancer.

Who is the study for?

This trial is for adults over 18 with a confirmed diagnosis of Glioblastoma (GBM) who have measurable disease after standard treatments. They should be able to perform daily activities with relative ease (ECOG ≤2), and have a life expectancy greater than 3 months. It's not suitable for those on diabetes medication, steroids, or with major organ failure, pregnant women, or anyone unable to follow the diet.Check my eligibility

What is being tested?

The study tests an energy restricted ketogenic diet (ERKD) that aims to maintain low blood sugar levels while increasing ketones in the body. This dietary approach has been used in children with seizures and may help shrink or stabilize primary brain tumors.See study design

What are the potential side effects?

While this ketogenic diet is generally well tolerated by children treating seizures and minimal side effects are reported even after long-term use, potential side effects specific to brain cancer patients will be closely monitored throughout the study.

Ketones Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am over 18 and have a confirmed diagnosis of GBM.

Select...

I can take care of myself and perform daily activities.

Select...

My cancer can still be measured after standard treatments.

Ketones Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks after completion of radiation therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks after completion of radiation therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks after completion of radiation therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Ketones Trial Design

1Treatment groups

Experimental Treatment

Group I: Obsrvational study adding ketogenic diet to standard initial treatment of glioblastom multiformeExperimental Treatment1 Intervention

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Michigan State UniversityLead Sponsor

185 Previous Clinical Trials

602,011 Total Patients Enrolled

Sparrow Health SystemOTHER

7 Previous Clinical Trials

870 Total Patients Enrolled

Kenneth Schwartz, MDPrincipal InvestigatorMichigan State University

Media Library

Energy Restricted Ketogenic Diet (Metabolic Nutritional Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01535911 — N/A

Glioblastoma Research Study Groups: Obsrvational study adding ketogenic diet to standard initial treatment of glioblastom multiforme

Glioblastoma Clinical Trial 2023: Energy Restricted Ketogenic Diet Highlights & Side Effects. Trial Name: NCT01535911 — N/A

Energy Restricted Ketogenic Diet (Metabolic Nutritional Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01535911 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants still being incorporated into this experiment?

"Unfortunately, the trial is not currently enrolling patients. Clinicaltrials.gov indicates that this particular study was posted on April 1st 2012 and last updated on April 28th 2022; however, there are still 796 other clinical studies actively seeking participants for their respective trials."

Answered by AI

Are elderly patients with this condition being included in the research?

"According to the inclusion criteria, those eligible for this trial should be aged from 18-90. Alternatively, there are a total of 101 clinical trials available for minors and 725 suitable studies offered to seniors."

Answered by AI

Is it possible to enlist in this research endeavor?

"This clinical trial is accepting individuals with glioblastoma, aged 18 to 90. To be eligible for the study, potential participants must have a confirmed diagnosis of GBM and an Eastern Cancer Oncology Group performance status less than or equal to 2; additionally they are required to possess a life expectancy greater than three months."

Answered by AI

Recent research and studies

Epilepsy ResearchJournal

Is the Restricted Ketogenic Diet a Viable Alternative to the Standard of Care for Managing Malignant Brain Cancer?

Seyfried, Thomas N., Jeremy Marsh, Laura M. Shelton, Leanne C. Huysentruyt, and Purna Mukherjee. 2012. “Is the Restricted Ketogenic Diet a Viable Alternative to the Standard of Care for Managing Malignant Brain Cancer?”. Epilepsy Research. Elsevier BV. doi:10.1016/j.eplepsyres.2011.06.017.

Cancer & MetabolismJournal

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

Schwartz, Kenneth, Howard T Chang, Michele Nikolai, Joseph Pernicone, Sherman Rhee, Karl Olson, Peter C Kurniali, Norman G Hord, and Mary Noel. 2015. “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 & Metabolism. Springer Science and Business Media LLC. doi:10.1186/s40170-015-0129-1.

clinicaltrials.govStudy

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

Kenneth Schwartz, MD 2012. "Pilot Study of a Metabolic Nutritional Therapy for the Management of Primary Brain Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01535911.

All > Osteopenia > Glioblastoma Multiforme