Ketogenic Therapy for Brain Cancer

(GLAD-KE Trial)

KC
Overseen ByKarisa C Schreck, MD, PhD.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Must be taking: Corticosteroids
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a Ketogenic Diet (high in fats and low in carbs) or a ketone supplement is safe and practical for individuals with recurring glioma, a type of brain cancer, who are undergoing surgery. Participants will either follow a special diet or take a supplement for a week before their surgery. The trial seeks individuals diagnosed with glioma, who have experienced a recurrence after previous treatment, and are preparing for surgery. As an unphased trial, it offers a unique opportunity to contribute to pioneering research that could enhance future treatment options.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you must be on a stable or decreasing dose of dexamethasone (a type of steroid) before starting. You should also minimize medications containing carbohydrates.

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

A previous study found the ketogenic diet (KD) safe for people with glioblastoma, a type of brain cancer. It was used alongside standard treatments like surgery and radiation. Another analysis showed that the KD does not harm important health indicators in cancer patients, suggesting the diet is generally safe, though researchers continue to study its long-term effects.

For the ketone supplement, less information is available. The trial phase is "Not Applicable," indicating limited safety data from clinical trials for the supplement. However, previous studies have shown that the ketogenic diet, which raises ketone levels similar to the supplement, is safe. While more specific research on ketone supplements would be ideal, the diet's safety record offers some reassurance.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for brain cancer because they harness the body's natural metabolic processes to target cancer cells. Unlike standard treatments such as surgery, chemotherapy, and radiation, which directly attack cancer cells, the ketogenic diet and ketone supplements work by altering the energy source of the cells. Cancer cells typically thrive on glucose, but these treatments limit glucose availability and instead increase ketones, which normal cells can use efficiently but cancer cells struggle with. This metabolic shift could potentially slow tumor growth while minimizing damage to healthy cells, offering a less invasive and potentially less toxic alternative to traditional therapies.

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

Research has shown that ketogenic diets and ketone supplements, both under investigation in this trial, may help treat brain tumors like gliomas. Participants will either follow a ketogenic diet or take ketone supplements. Studies have found that increasing blood ketone levels can slow tumor growth. In animal studies, ketone supplements reduced active tumor cells and extended lifespan. In humans, ketogenic diets have been linked to ketosis, a stable state where the body uses fat for energy, and have been associated with smaller tumors and longer survival. These findings suggest that ketogenic diets and ketone supplements could complement traditional cancer treatments.678910

Who Is on the Research Team?

KC

Karisa C Schreck, MD, PhD.

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults with recurrent glioma (a type of brain cancer) who are scheduled to have surgery. Participants must be able to follow a special diet or take supplements before their operation.

Inclusion Criteria

I have a glioma that has come back after radiation treatment.
AST (SGOT) and ALT (SGPT) < 2.5 x institutional ULN
Willing to submit archival tumor sample if available
See 13 more

Exclusion Criteria

Contraindication to MRI including cardiac pacemaker, insulin pumps, non-MRI-compatible stents/clips/plates/rods, non-removable glucose monitor, or other non-removable ferromagnetic objects in body
I do not have any active, uncontrolled infections.
Conditions increasing risk of study intervention or reducing compliance (e.g. cognitive impairment, frank dementia)
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-treatment

Participants begin either a ketogenic diet or ketone supplementation for 7 days prior to surgery

7 days
Daily self-administration

Surgery

Participants undergo clinically indicated surgery after 7 days of dietary intervention

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days
Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Ketogenic Diet
  • Ketone Supplement

Trial Overview

The study compares two approaches: one group follows a ketogenic (low-carb, high-fat) diet for 7 days before surgery, while the other takes daily ketone supplements. The goal is to see if these methods are safe and practical.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Ketone supplementExperimental Treatment1 Intervention
Group II: Ketone dietExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials
578
Recruited
33,600+

Ludwig Institute for Cancer Research

Collaborator

Trials
62
Recruited
1,700+

Kenetik

Collaborator

Citations

Ketogenic diet for Glioblastoma and Brain tumors

The ketogenic diet increases ketone bodies in the blood, having been observed in studies to produce reductions in brain tumors.

Treatment of glioma patients with ketogenic diets

One recent retrospective study reported the outcomes from six patients who implemented a ketogenic diet as adjunctive or complementary therapy with chemo ...

Treatment of malignant gliomas with ketogenic or caloric ...

Ketone supplementation decreases tumor cell viability and prolongs survival of mice with metastatic cancer. an effective alternative therapy for ma- lignant ...

Ketogenic Diet With Radiation and Chemotherapy for ...

This study aims to see if reducing blood sugar and increasing ketones (a metabolic product that comes from using fats for energy) can increase survival and ...

The Ketogenic Diet Is an Effective Adjuvant to Radiation ...

Studies in mice with malignant glioma have demonstrated that KD may reduce tumor growth and prolong survival [48,49]. , it enhanced the ...

Ketogenic Metabolic Therapy for Glioma

The mean (SD) progression-free survival while patients maintained ketogenic metabolic therapy was 20.0 (14.4) months.

UC experts explore if ketogenic diet could help make ...

The use of KD as adjuvant to standard treatment, with chemoradiation after first surgery, is feasible and safe in patients with glioblastoma ...

The Ketogenic Diet Alters the Hypoxic Response and Affects ...

The KD directly or indirectly alters the expression of several proteins involved in malignant progression and may be a useful tool for the treatment of gliomas.

Safety of ketogenic diets for people with cancer - Study ...

This meta-analysis found that a ketogenic diet does not adversely affect several biomarkers of health in people with cancer, but the long-term effects are ...

Glioblastoma and Ketogenic Metabolic Therapy

Safety and Efficacy: A recent systematic review and meta-analysis concludes that 'current evidence supports the KD as a safe, feasible, and ...