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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 16 weeks

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

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

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

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

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