Investigating ketogenic diets for patients with brain metastases
Keto-Brain: Investigating the Use of Ketogenic Diets in Brain Metastases
This study is testing whether a ketogenic diet can help improve the treatment outcomes and quality of life for people with brain metastases compared to a different diet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT05428852 on ClinicalTrials.gov |
What this trial studies
This pilot study is a single center, randomized controlled trial involving 24 participants diagnosed with brain metastases. It compares the effects of a ketogenic diet against an alternative diet over a 16-week intervention period. Participants will receive education, recipes, and food supplies to support their assigned diet, while their quality of life will be monitored through psychosocial and behavioral inventories. The study aims to explore how a ketogenic diet may enhance the effectiveness of surgery and radiation therapy in treating brain metastases.
Who should consider this trial
Good fit: Ideal candidates are adults with measurable brain lesions, a BMI of 18 kg/m2 or higher, and an ECOG performance status of 0-1.
Not a fit: Patients undergoing whole brain radiation therapy or with certain medical conditions such as type 1 diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel dietary approach to improve treatment outcomes for patients with brain metastases.
How similar studies have performed: While there have been preclinical studies suggesting benefits of ketogenic diets in enhancing cancer treatment, this specific approach in brain metastases is novel and has not been extensively tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 this trial is running
Columbus, Ohio
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Jeff Volek, PhD — Ohio State University Comprehensive Cancer Center
- Study coordinator: The Ohio State University Comprehensive Cancer Center
- Email: OSUCCCClinicaltrials@osumc.edu
- Phone: 800-293-5066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.