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Dietary Intervention

Ketogenic Diet for Brain Cancer

N/A
Recruiting
Led By Jeff Volek, PhD
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Graded Prognostic Assessment > 1.5
Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1 (0=participant has either normal activity, 1= participant has some symptoms but is nearly full ambulatory)
Must not have
No previous or suspected leptomeningeal disease
Type 1 diabetes or insulin-dependent Type II diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 16 weeks
Awards & highlights

Summary

This trial will compare the effect of a ketogenic diet and the American Institute for Cancer Research diet on 24 people with bone marrow cancer. Research dietitians will provide education, recipes, and grocery lists for the assigned diet, and patients will complete quality of life surveys every 4 weeks.

Who is the study for?
This trial is for adults with brain tumors who have measurable lesions, are in good physical condition (able to perform normal activities or are mostly ambulatory), and can follow a special diet. They should not be undergoing whole brain radiation, pregnant, nursing, or have certain conditions like Type 1 diabetes or severe kidney issues.Check my eligibility
What is being tested?
The Keto-Brain study compares the effects of a ketogenic diet versus an AICR diet on patients with brain metastases over 16 weeks. Participants will receive dietary guidance and food supplies from research dietitians and complete regular health questionnaires.See study design
What are the potential side effects?
Potential side effects may include changes in energy levels, digestive discomforts related to dietary changes, blood sugar fluctuations especially in those predisposed to diabetes, and possible nutrient deficiencies without proper management.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My brain tumor prognosis score is above 1.5.
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I am mostly active but may have some symptoms.
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I am scheduled for stereotactic radiosurgery (SRS).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have never had cancer spread to the lining of my brain and spinal cord.
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I have diabetes and need insulin.
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I am unable to understand or sign the consent form.
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I have never been diagnosed with small cell lung cancer.
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My kidney function is not normal, and I can't have an MRI.
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I am not willing to follow a specific diet plan.
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I am receiving radiation therapy for my whole brain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of maintaining a ketogenic diet in patients with brain metastasis selected for radiosurgery
Feasibility of maintaining a ketogenic versus AICR diet in patients with brain metastasis selected for radiosurgery
Metabolic outcomes of a ketogenic versus AICR diet in patients with brain metastasis selected for radiosurgery
+1 more
Secondary outcome measures
Preliminary effects of the ketogenic versus AICR diet on Heart Hope Scale in BM individuals undergoing radiation therapy to asses quality of life
Preliminary effects of the ketogenic versus AICR diet on Neurocognitive Function Scores in BM individuals undergoing radiation therapy
Preliminary effects of the ketogenic versus AICR diet on PROMIS Cognitive Function Short Form 8a Scores in BM individuals undergoing radiation therapy

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of Care + Ketogenic DietExperimental Treatment5 Interventions
(standard of care, ketogenic diet) Patients receive standard of care with SRS. Patients undergo a controlled feeding period ketogenic diet comprising of meals for the first week and then transition into a free living with guided support type of intervention.
Group II: Standard of CareActive Control4 Interventions
Patients receive standard of care therapy with SRS and AICR Diet education.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dietary Intervention
2014
Completed Phase 2
~2550
Fitbit
2021
N/A
~3560

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
325 Previous Clinical Trials
290,580 Total Patients Enrolled
Jeff Volek, PhDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
4 Previous Clinical Trials
473 Total Patients Enrolled

Media Library

Ketogenic Diet (Dietary Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05428852 — N/A
Brain Metastases Research Study Groups: Standard of Care, Standard of Care + Ketogenic Diet
Brain Metastases Clinical Trial 2023: Ketogenic Diet Highlights & Side Effects. Trial Name: NCT05428852 — N/A
Ketogenic Diet (Dietary Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05428852 — N/A
~8 spots leftby Jul 2025
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