Ketogenic Diet for Brain Cancer

Overseen By Madison Kackley, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Whole brain radiation, Pregnancy, Small cell lung carcinoma, Leptomeningeal disease, Type 1 diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how different diets might help people with brain cancer. Participants will follow either a ketogenic diet (low-carb, high-fat) or a diet from the American Institute for Cancer Research (AICR) while receiving standard cancer care. The goal is to determine if these diets can improve quality of life and other health outcomes. Individuals with measurable brain lesions on an MRI, good overall health, and the ability to follow specific diet plans may qualify. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on dietary impacts in brain cancer care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that a ketogenic diet is generally safe for people with brain tumors. One study found it safe and manageable for patients with glioblastoma (a type of brain cancer) who were also receiving standard treatments, with no major safety issues reported. Additionally, following this diet might help people with brain tumors live longer.

Other studies have shown that a ketogenic diet can lead to better outcomes for cancer patients compared to non-ketogenic diets. While individual experiences may vary, these findings suggest that the ketogenic diet does not pose significant safety risks for those considering a clinical trial that includes this diet. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for brain cancer, which typically involves surgery, radiation, and chemotherapy, the ketogenic diet offers a completely different approach by altering metabolism. Researchers are excited about this treatment because it shifts the body's energy source from glucose to fats, potentially starving cancer cells that thrive on sugar. This diet not only provides a non-invasive option but also has the potential to improve the effectiveness of existing treatments when used in combination.

What evidence suggests that this trial's diets could be effective for brain cancer?

Research suggests that the ketogenic diet, high in fats and low in carbohydrates, might extend the lives of people with brain tumors like glioblastoma. Some studies have found that this diet can lower body fat, insulin, and blood sugar levels, and may also reduce tiredness and sleep issues. In this trial, one group of participants will receive standard care with SRS and AICR Diet education, while another group will receive standard care combined with the ketogenic diet. Although the ketogenic diet has slowed tumor growth, concerns remain about its potential to aid cancer spread. Overall, the ketogenic diet shows promise for patients, but more research is needed to fully understand its effects. ^{1 3 4 5 6}

Who Is on the Research Team?

Jeff Volek, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My brain tumor prognosis score is above 1.5.

I am mostly active but may have some symptoms.

I am scheduled for stereotactic radiosurgery (SRS).

Exclusion Criteria

I have never had cancer spread to the lining of my brain and spinal cord.

I have diabetes and need insulin.

I am unable to understand or sign the consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diet Intervention

Participants undergo a 16-week diet intervention with either a ketogenic or AICR diet, including education, recipes, and grocery lists provided by research dietitians.

16 weeks

Regular visits for diet monitoring and support

Follow-up

Participants are monitored for safety, effectiveness, and quality of life after the diet intervention.

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Ketogenic Diet

Trial Overview

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.

How Is the Trial Designed?

Group I: Standard of Care + Ketogenic Diet Experimental Treatment 5 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 Care Active Control 4 Interventions

Patients receive standard of care therapy with SRS and AICR Diet education.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Published Research Related to This Trial

The ketogenic dietary intervention, known as the Glioma Atkins-Based Diet (GLAD), was feasible and safe for 25 patients with glioma, with 84% completing the 8-week study and significant metabolic changes observed, including increased ketone levels in the brain.

The diet led to meaningful systemic changes, such as decreased insulin and hemoglobin A1c levels, and increased ketone concentrations in both the tumor and healthy brain tissue, suggesting that ketonuria is a reliable indicator of metabolic activity in the brain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Biological Activity of a Ketogenic/Intermittent-Fasting Diet in Patients With Glioma. Schreck, KC., Hsu, FC., Berrington, A., et al.[2022]

In a case series of 12 patients with central nervous system malignancies, those who followed a ketogenic diet for 120 days showed maintained ketone levels and decreased glucose levels, suggesting a potential metabolic advantage in managing their condition.

Patients reported improved symptoms and imaging indicated better disease control and reduced swelling, highlighting the need for further structured clinical trials to explore the efficacy of the ketogenic diet as an adjunct therapy for CNS tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Feasibility and Effects of a Ketogenic Diet in Patients With CNS Malignancies: A Retrospective Case Series. Panhans, CM., Gresham, G., Amaral, LJ., et al.[2020]

A review of 13 studies involving 187 glioma patients indicates that ketogenic diets (KD) may inhibit glioma growth and help manage symptoms, but there is significant variability in how these diets are implemented.

The lack of standardization in ketogenic diet protocols for glioma patients complicates comparisons of their effectiveness, highlighting the need for a consensus on dietary definitions and methods to optimize treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methodological Approaches to Ketogenic Dietary Treatments in Glioma Patients from a Nutritional Point of View. Guo, A., Asztely, F., Smits, A., et al.[2022]

The ERGO2 trial, involving 50 patients with recurrent brain tumors, found that a calorie-restricted ketogenic diet combined with intermittent fasting did not improve progression-free survival compared to a standard diet, despite achieving significant metabolic changes in those on the ketogenic diet.

Patients on the ketogenic diet successfully met their dietary goals, leading to notable decreases in leptin and insulin levels, while low glucose levels were identified as a potential marker for better prognosis, although quality of life and cognitive function remained unaffected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term fasting in glioma patients: analysis of diet diaries and metabolic parameters of the ERGO2 trial. Voss, M., Wenger, KJ., von Mettenheim, N., et al.[2022]

The restricted ketogenic diet (RKD) targets energy metabolism in malignant brain cancer by reducing glucose and glutamine availability, which are crucial for tumor growth, and has shown anti-cancer effects in mouse models.

Case reports indicate that the RKD can be an effective non-toxic treatment option for malignant gliomas in humans, potentially enhancing the efficacy of existing therapies that also target glucose and glutamine metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is the restricted ketogenic diet a viable alternative to the standard of care for managing malignant brain cancer? Seyfried, TN., Marsh, J., Shelton, LM., et al.[2017]

In a study of 200 older patients (median age 70) on a ketogenic diet, 67% reported beneficial outcomes, including significant weight loss for 79% of those seeking it, improved glucose control for 54% of those with diabetes, and positive effects on cancer outcomes for 63% of patients pursuing that goal.

While the ketogenic diet showed promise for various health issues in older adults, 15% of participants experienced adverse events, including dyslipidemia and constipation, highlighting the need for careful monitoring in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can older patients adopt and maintain a ketogenic diet? An observational study in support of clinical trials in older patients. Almodallal, Y., Cook, K., Lammert, LM., et al.[2023]

The calorically restricted ketogenic diet (CRKD) shows promise as an alternative therapy for brain cancer, effectively managing tumor growth in both animal models and patients.

The CRKD may work through several mechanisms, including reducing blood vessel formation (antiangiogenic), decreasing inflammation (anti-inflammatory), and promoting cell death in tumor cells (proapoptotic), which is particularly relevant since brain tumor cells struggle to use ketone bodies for energy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting energy metabolism in brain cancer with calorically restricted ketogenic diets. Seyfried, TN., Kiebish, M., Mukherjee, P., et al.[2017]

A modified ketogenic diet (MKD) was well tolerated by glioma patients, with only minor side effects like constipation reported, and it was achievable within a standard healthcare service.

Out of 172 surveyed patients, 69% supported offering MKD as a treatment option, and 73% expressed willingness to try it for 3 months, indicating strong interest in future clinical trials to assess its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Modified Ketogenic Diet in Adults with Glioblastoma: An Evaluation of Feasibility and Deliverability within the National Health Service. Martin-McGill, KJ., Marson, AG., Tudur Smith, C., et al.[2022]

The restricted KetoCal diet significantly reduced tumor growth in mouse models of malignant brain cancer, decreasing growth by about 65% for CT-2A tumors and 35% for U87-MG tumors, while also improving overall health and survival compared to a standard high carbohydrate diet.

KetoCal's effectiveness is attributed to its ability to lower plasma glucose levels and increase ketone bodies, exploiting the tumors' reliance on glucose for energy, suggesting that this diet could be a safe and effective alternative therapy for managing malignant brain cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The calorically restricted ketogenic diet, an effective alternative therapy for malignant brain cancer. Zhou, W., Mukherjee, P., Kiebish, MA., et al.[2020]

A ketogenic diet (KD) combined with standard treatments for aggressive primary brain tumors (APBT) showed promising results, with three younger patients surviving significantly longer (52-74 months) compared to older patients, who had an average survival of 8 months after diagnosis.

The study demonstrated that it is feasible to maintain dietary-induced ketosis in patients with APBT, suggesting that further research is needed to explore the potential benefits of KD, particularly in younger patients under 40.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long Term Survivals in Aggressive Primary Brain Malignancies Treated With an Adjuvant Ketogenic Diet. Schwartz, KA., Noel, M., Nikolai, M., et al.[2023]

A ketogenic diet (KD) was found to be feasible and safe for patients undergoing standard chemoradiation treatment for glioblastoma multiforme, with no severe adverse effects reported during the study.

Of the 11 patients who started the study, 67% completed the KD protocol, and overall survival ranged from 9.8 to 19.0 months, suggesting potential benefits that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketogenic diet treatment as adjuvant to standard treatment of glioblastoma multiforme: a feasibility and safety study. van der Louw, EJTM., Olieman, JF., van den Bemt, PMLA., et al.[2022]

The pilot study of a 4:1 ketogenic diet (KD) using a total meal replacement program for glioblastoma (GBM) patients showed that the diet was well tolerated, with mild and transient treatment-emergent adverse events, and 62.5% of participants completed the 6-month treatment.

Survival times were promising, with a mean of 20 months for newly diagnosed patients and 12.8 months for recurrent GBM patients after starting the KD, suggesting potential benefits, although the small sample size limits definitive conclusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of glioblastoma multiforme with "classic" 4:1 ketogenic diet total meal replacement. Klein, P., Tyrlikova, I., Zuccoli, G., et al.[2020]

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This phase 1 trial demonstrates that KD is safe and feasible for GBM patients receiving SOC, may improve outcomes, and provides a foundation for an NCI-funded ...

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A phase 1 safety and feasibility trial of a ketogenic diet plus ...

This phase 1 trial demonstrates that KD is safe and feasible for GBM patients receiving SOC, may improve outcomes, and provides a foundation for an NCI-funded ...