Keto-Brain:Investigating the Use of Ketogenic Diets in Brain Metastases

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Conditions studied: Brain Metastases, Adult

In brief

This pilot study will be a single center, randomized controlled study of 24 participants with diagnosed BM (various primary disease sites) comparing the effect of a ketogenic (n=12) and AICR (n=12) diet. Potential participants will be identified via medical record reviews and chart reviews. Eligibility of patients will be assessed via medical record review. Randomization will be balanced by blocks of random sizes but no stratification due to the small sample size. Both groups will undergo a 16-week diet intervention where research dietitians will provide educations, recipes and grocery lists on the participants assigned diet. Each group will receive 4-7 days worth of food prior to testing days to both aid in transitioning to each dietary arm and to ensure that the metabolic needs for each arm are met. In an effort to maintain a patient centric focus and monitor changes in quality of life (QOL) all patients will complete psychosocial and behavioral inventories. These inventories aim to capture a holistic view on the proposed nutritional intervention during treatment. Primary outcomes will be determined at baseline, 8 weeks, and 16 weeks while patient-centric outcomes will be assessed every four weeks. Participants will have counseling by the attending physician for additional applicable medications for any treatment related side effects or toxicities. The intervention groups will undergo their randomized dietary regimen for 16 weeks.

Key facts

Study ID

NCT05428852

Run by

Ohio State University Comprehensive Cancer Center

People needed

24

Starts

2022-09-26

Expected to finish

2026-10-31

Last updated by the study team

2026-02-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Measurable brain lesions noted on baseline MRI imaging
• Graded Prognostic Assessment > 1.5
• Body mass index (BMI) ≥18 kg/m2
• 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)
• Able and willing to follow prescribed diet intervention
• Scheduled to receive SRS
• Exclusion Criteria:• Undergoing whole brain radiation therapy
• BMI <18 kg/m2
• Pregnant or nursing women
• Not willing to be randomized into either of the dietary interventions
• Unable to provide Informed Consent
• No previous diagnosis of small cell lung carcinoma
• No previous or suspected leptomeningeal disease
• Type 1 diabetes or insulin-dependent Type II diabetes
• Abnormal renal function (GFR < 55 mL/min, creatinine >2.0, urinary albumin >1 g/day) Not MRI eligible

Where it is running

• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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