Status:
RECRUITING
Keto-Brain:Investigating the Use of Ketogenic Diets in Brain Metastases
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Conditions:
Brain Metastases, Adult
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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) di...
Detailed Description
Neurological tissues are among the most common (\>10% of cancer patients) and debilitating sites for metastatic disease to develop. The brain is a 'sanctuary site' for many cancer cells and remains a ...
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
September 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05428852
Start Date
September 26 2022
End Date
October 31 2026
Last Update
January 31 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210