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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 16 weeks
Awards & highlights
Study 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 belowSelect...
My brain tumor prognosis score is above 1.5.
Select...
I am mostly active but may have some symptoms.
Select...
I am scheduled for stereotactic radiosurgery (SRS).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 16 weeks
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 moreSecondary 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
322 Previous Clinical Trials
290,253 Total Patients Enrolled
Jeff Volek, PhDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
3 Previous Clinical Trials
436 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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).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.I have never been diagnosed with small cell lung cancer.My kidney function is not normal, and I can't have an MRI.I am not willing to follow a specific diet plan.I am receiving radiation therapy for my whole brain.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care
- Group 2: Standard of Care + Ketogenic Diet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research project currently have openings for participants?
"Per the clinicaltrials.gov website, this medical study is currently open to candidates. It was initially published on October 1st 2022 and last updated on September 19th of the same year."
Answered by AI
Does the study encompass individuals aged fifty and above?
"Eligible patients for this trial must be 18 years of age or above and not exceed 75 years old."
Answered by AI
Is eligibility for this research open to me?
"This medical trial is actively enrolling 24 individuals between the ages 18 and 75 with a diagnosis of brain; additional criteria include measurable lesions on MRI scans, Graded Prognostic Assessment greater than 1.5, BMI above 18kg/m2, ECOG Performance status 0-1 (0= normal activity or 1 = some symptoms but ambulatory), compliance to dietary intervention and scheduled SRS treatment."
Answered by AI
How many individuals have elected to be part of this experiment?
"Affirmative. The details available on clinicaltrials.gov reveal that this investigation has been actively recruiting since October 1st 2022, with the last update to their patient recruitment protocol occurring on September 19th 2022. This study is searching for 24 participants at a single medical centre."
Answered by AI
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