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Metabolic Nutritional Therapy

Ketogenic Diet for Brain Cancer (Ketones Trial)

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

Must not have

Active malignancy other than primary brain tumor requiring therapy

Inability to give informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks after completion of radiation therapy

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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

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I can take care of myself and perform daily activities.

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My cancer can still be measured after standard treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have cancer that needs treatment, but it's not a primary brain tumor.

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I am unable to understand and agree to the study's details.

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I have diabetes and am taking medication for it.

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I do not have major health issues like liver, kidney, or heart failure.

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I am currently taking glucocorticosteroids.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 8Eligibility criteria met