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

NCT05428852 | Suspended DMC

• 3 other identifiers: 2020C0046NCI-2023-10603OSU-19277
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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) 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

Brain Metastases, Adult

Outcome Measures

Primary Outcomes (4)

• Feasibility of maintaining a ketogenic versus AICR diet in patients with brain metastasis selected for radiosurgery

  Summaries from questionnaires will be plotted over time to assess adherence and compliance to the ketogenic diet.

  Up to 16 weeks

• Feasibility of maintaining a ketogenic diet in patients with brain metastasis selected for radiosurgery

  Summaries from ketone logs will be plotted over time to assess adherence and compliance to the ketogenic diet.

  Up to 16 weeks

• Metabolic outcomes of a ketogenic versus AICR diet in patients with brain metastasis selected for radiosurgery

  Summaries from blood markers will be plotted over time to assess adherence and compliance to the ketogenic diet.

  Up to 16 weeks

• Number of Participants with partial-or-complete response according to RECIST v1.1

  use a Chi-squared test for the association between treatment group and partial-or-complete response according to RECIST v1.1

  Baseline up to 16 weeks

Secondary Outcomes (3)

• Preliminary effects of the ketogenic versus AICR diet on Neurocognitive Function Scores in BM individuals undergoing radiation therapy

  Baseline up to 16 weeks

• Preliminary effects of the ketogenic versus AICR diet on PROMIS Cognitive Function Short Form 8a Scores in BM individuals undergoing radiation therapy

  Baseline up to 16 weeks

• Preliminary effects of the ketogenic versus AICR diet on Heart Hope Scale in BM individuals undergoing radiation therapy to asses quality of life

  Baseline up to 16 weeks

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Patients receive standard of care therapy with SRS and AICR Diet education.

Other: Laboratory Biomarker Analysis; Other: Neurocognitive Assessment; Other: Questionnaire Administration; Device: Fitbit

Standard of Care + Ketogenic Diet

EXPERIMENTAL

(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.

Other: Laboratory Biomarker Analysis; Other: Neurocognitive Assessment; Other: Questionnaire Administration; Device: Fitbit; Dietary Supplement: Dietary Intervention

Interventions

Laboratory Biomarker Analysis OTHER

Correlative Studies

Standard of Care; Standard of Care + Ketogenic Diet

Neurocognitive Assessment OTHER

NRG-CC

Standard of Care; Standard of Care + Ketogenic Diet

Questionnaire Administration OTHER

Ancillary studies

Standard of Care; Standard of Care + Ketogenic Diet

Fitbit DEVICE

Fitbit Activity Tracking

Standard of Care; Standard of Care + Ketogenic Diet

Dietary Intervention DIETARY_SUPPLEMENT

Undergo ketogenic diet

Standard of Care + Ketogenic Diet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Mental Status and Dementia Tests; Diet Therapy

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities; Nutrition Therapy; Therapeutics

Study Officials

• Jeff Volek, PhD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 23, 2022
• Study Start: September 26, 2022
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

US (1)