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

Launched by OHIO STATE UNIVERSITY COMPREHENSIVE CANCER CENTER · Jun 17, 2022

Keywords

ClinConnect Summary

The Keto-Brain study is exploring whether a ketogenic diet, which is low in carbohydrates and high in fats, can help people with brain metastases, which are cancerous tumors that have spread to the brain from other parts of the body. This study will involve 24 participants who will be randomly assigned to either follow a ketogenic diet or a different diet for 16 weeks. Throughout the study, participants will receive support from dietitians, including meal plans and food supplies to help them transition to their assigned diet. Researchers will monitor how the diets impact participants' health and quality of life at various points during the study.

To be eligible for the trial, participants must have measurable brain lesions seen on MRI scans and a body mass index (BMI) of at least 18. They should also be able to follow the prescribed diet and be scheduled to receive a specific type of radiation therapy called Stereotactic Radiosurgery (SRS). However, individuals who are pregnant, have certain health conditions like type 1 diabetes, or are undergoing whole brain radiation therapy will not be eligible. Participants can expect regular check-ins to discuss their progress and any treatment-related side effects, ensuring they receive the care they need throughout the study.

Gender

ALL

Eligibility 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