What side effects are associated with this type of intervention?

The ketogenic diet, which is high in fat and low in carbohydrates, can lead to side effects such as gastrointestinal discomfort, nutrient deficiencies, and increased cholesterol levels. Metformin, commonly used to lower blood glucose levels, may cause gastrointestinal issues like nausea, diarrhea, and abdominal pain. In the context of Glioblastoma, other common treatments include chemotherapy and radiation, which can result in side effects such as fatigue, hair loss, nausea, vomiting, and increased risk of infections.

What prior FDA approvals exist?

The FDA has approved several treatments for Glioblastoma, including temozolomide, which is often used in conjunction with radiotherapy. Temozolomide is an oral chemotherapy drug that has shown efficacy in extending survival in patients with Glioblastoma. Bevacizumab, an angiogenesis inhibitor, has also been approved for recurrent Glioblastoma. While there are no specific FDA approvals for treatments that lower blood glucose levels in Glioblastoma, the ongoing study of the ketogenic diet and metformin aims to explore this novel approach by targeting the metabolic pathways of the tumor.

What other types of research exist?

Promising novel alternatives to the ketogenic diet and metformin for glioblastoma patients may include therapies targeting metabolic pathways such as Glucagon-like Peptide 1 (GLP-1) receptor agonists, which have shown potential in diabetes management and may influence cancer metabolism. Additionally, emerging research on specific dietary supplements with immune-stimulatory and anticancer properties, such as selected vegetables and herb mix (SV), could be considered. Further investigation and clinical trials are warranted to establish their efficacy and safety in glioblastoma treatment.

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Ketogenic Diet + Metformin for Glioblastoma

Phase 2

Recruiting

Led By Howard Fine, MD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

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

Must have

Patients must have an MRI performed within 21 days prior to beginning the study diet and on a fixed dose of steroids for at least 5 days. If the steroid dose is increased between the date of imaging and registration, a new baseline MR/CT is required.

Patients must not have been exposed to bevacizumab.

Must not have

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, diabetes requiring oral hypoglycemic drugs and/or insulin, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Patients who have had prior therapy with bevacizumab and/or other VEGF inhibitors.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion (an average of 8 months)

Awards & highlights

Summary

This trial is for men and women with aggressive brain tumors. It uses a high-fat, low-carb diet and a diabetes medication to lower blood sugar levels. The goal is to see if this approach can help slow down tumor growth. The high-fat, low-carb diet is being explored as an additional treatment for brain tumors, with some studies suggesting it may help control tumor growth and improve response to standard treatments.

Who is the study for?

This trial is for adults over 18 with high-grade gliomas who haven't had bevacizumab therapy. They should not have diabetes requiring medication, no recent malignancy treatments (except certain skin cancers), and no severe illnesses that could affect study participation. Participants must be able to prepare meals and follow a ketogenic diet with metformin, without experiencing unacceptable side effects.

What is being tested?

The trial tests the combination of a ketogenic diet and metformin on patients with high-grade gliomas. The goal is to see if this regimen can lower blood glucose levels which may contribute to slowing tumor growth. Patients will work with a nutritionist to manage their diet while taking metformin.

What are the potential side effects?

Potential side effects include low blood sugar, digestive issues from the ketogenic diet such as constipation or diarrhea, changes in cholesterol levels, weight loss, and possible vitamin deficiencies. Metformin may cause stomach upset or a rare condition called lactic acidosis.

Eligibility Criteria

Inclusion Criteria

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

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I had an MRI within the last 3 weeks and have been on a stable steroid dose for at least 5 days.

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I have never been treated with bevacizumab.

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I am older than 18 years.

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I am able to care for myself but may not be able to do active work.

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I do not have diabetes and don't expect to need diabetes medication soon.

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I have been diagnosed with a high-grade brain tumor.

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My kidney function is good.

Exclusion Criteria

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

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I do not have any serious illnesses that are not under control.

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I have previously been treated with bevacizumab or other drugs that target blood vessel growth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion (an average of 8 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion (an average of 8 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion (an average of 8 months) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Ability to achieve and maintain ketosis

Tolerability of metformin

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221

13%

Nasopharyngitis

10%

Hyperhidrosis

Hunger

Tremor

Asthenia

Hypoglycaemia

Femoral neck fracture

Squamous cell carcinoma of the tongue

100%

80%

60%

40%

20%

Study treatment Arm

Vildagliptin (LAF237)

Placebo

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ketogenic DietExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metformin

2006

Completed Phase 4

~2430

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Glioblastoma treatments traditionally include surgery, radiation, and chemotherapy, which aim to remove or destroy cancer cells. The ketogenic diet and metformin, as studied in the pilot trial, focus on lowering blood glucose levels, which is crucial because glucose fuels tumor growth. The ketogenic diet reduces carbohydrate intake, forcing the body to use fats for energy, thereby lowering glucose levels. Metformin, a diabetes medication, also lowers blood glucose and may inhibit tumor growth. These approaches are significant as they target the metabolic needs of glioblastoma cells, potentially slowing their growth and improving patient outcomes.