Clinical trial · Interventional
Keto-Brain:Investigating the Use of Ketogenic Diets in Brain Metastases
Keto-Brain: Investigating the Use of Ketogenic Diets in Brain Metastases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): IRB Approval Expiration
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases, Adult | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dietary Intervention | Dietary Supplement | — | UNRESOLVED |
| Fitbit | Device | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Neurocognitive Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard of Care
- description
- Patients receive standard of care therapy with SRS and AICR Diet education.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Other: Neurocognitive Assessment
- Other: Questionnaire Administration
- Device: Fitbit
- type
- EXPERIMENTAL
- label
- Standard of Care + Ketogenic Diet
- description
- (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.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Other: Neurocognitive Assessment
- Other: Questionnaire Administration
- Device: Fitbit
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available