Brain Metastases, AdultNCT05428852
Keto-Brain:Investigating the Use of Ketogenic Diets in Brain Metastases
A study testing Laboratory Biomarker Analysis, Neurocognitive Assessment and Questionnaire Administration in people with Brain Metastases, Adult, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Metastases, Adult
- What is being tested?
- Laboratory Biomarker Analysis, Neurocognitive Assessment and Questionnaire Administration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2022to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Keto-Brain: Investigating the Use of Ketogenic Diets in Brain Metastases
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.
Read the 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 challenging site to treat. Surgery and radiation therapies are the most common treatments. The investigators hypothesize that the metabolic adaptations associated with a well-formulated ketogenic diet that induces nutritional ketosis will significantly improve the response to surgery and radiation in patients with brain metastases. To date, numerous preclinical studies have demonstrated the ability of nutritional ketosis and caloric restriction to augment the therapeutic efficacy of radiotherapy. Use of a ketogenic diet is known to decrease the protein expression of HIF-1 and VEGFR2, and may increase radio sensitivity by normalizing tumor vasculature and increasing facilitated oxygen delivery to tumor cells. Several additional proposed mechanisms exist for enhancing radiosensitivity of the malignancy including: HDAC dependent mechanisms, ATP deprivation, mitochondrial ROS production and downregulation of IGF-1 receptor. Short-term fasting, a way to increase ketones acutely, has been demonstrated to speed up mitotic rates and thus facilitate a DNA damage sensitization. Lastly, a recent study showed that glucose restriction lowered Ki-67 expression, clonogenic frequency and rate of proliferation in gliomaspheres in vitro.
The investigating team team has an established expertise in conducting ketogenic diet interventions. Many individuals have adopted a low-carbohydrate diet for health reasons, yet there is scarce professional support available to provide guidance and support, especially for ketogenic diets. The investigators have scientific expertise and practical knowledge of both ketogenic and current standard of care cancer diets combined with a passion to empower people with the tools to implement these eating approaches into the participant's lifestyle. This project is highly patient-centered. The investigators will support patients who are randomized into either one of the intervention groups and provide them with a personalized eating plan designed to have maximal therapeutic impact and positively impact their lives. To that end, this project is unique in that it is highly patient-centered while also designed to have a substantial scientific and practical impact on medical management of brain metastasis treatments.
- Conditions
- Brain Metastases, Adult
- Being tested
- Laboratory Biomarker Analysis, Neurocognitive Assessment, Questionnaire Administration, Fitbit, Dietary Intervention
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative Studies
Neurocognitive AssessmentOther
NRG-CC
Questionnaire AdministrationOther
Ancillary studies
FitbitDevice
Fitbit Activity Tracking
Dietary InterventionDietary supplement
Undergo ketogenic diet
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Patients receive standard of care therapy with SRS and AICR Diet education. Receives: 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. Receives: Other: Laboratory Biomarker Analysis; Other: Neurocognitive Assessment; Other: Questionnaire Administration; Device: Fitbit; Dietary Supplement: Dietary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
same linear mixed effects model as for the primary objective, but with the following quality-of-life endpoints as outcomes
Measured: 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
same linear mixed effects model as for the primary objective, but with the following quality-of-life endpoints as outcomes
Measured: 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
same linear mixed effects model as for the primary objective, but with the following quality-of-life endpoints as outcomes
Measured: Baseline up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start26 Sep 2022
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Why it stopped: IRB Approval Expiration
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Metastases, AdultStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeff Volek, Ohio State University Comprehensive Cancer Center
- Investigators
- Jeff Volek, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428852
- Sponsor's protocol ID
- 2020C0046
- Other IDs
- NCI-2023-10603, OSU-19277
- Status last verified
- Feb 2026
- First submitted
- 14 Jun 2022
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Keto-Brain: Investigating the Use of Ketogenic Diets in Brain Metastases
- ClinicalTrials.gov ID
- NCT05428852
- Acronym / sponsor ID
- 2020C0046
- Conditions
- Brain Metastases, Adult
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: IRB Approval Expiration
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 23 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 challenging site to treat. Surgery and radiation therapies are the most common treatments. The investigators hypothesize that the metabolic adaptations associated with a well-formulated ketogenic diet that induces nutritional ketosis will significantly improve the response to surgery and radiation in patients with brain metastases. To date, numerous preclinical studies have demonstrated the ability of nutritional ketosis and caloric restriction to augment the therapeutic efficacy of radiotherapy. Use of a ketogenic diet is known to decrease the protein expression of HIF-1 and VEGFR2, and may increase radio sensitivity by normalizing tumor vasculature and increasing facilitated oxygen delivery to tumor cells. Several additional proposed mechanisms exist for enhancing radiosensitivity of the malignancy including: HDAC dependent mechanisms, ATP deprivation, mitochondrial ROS production and downregulation of IGF-1 receptor. Short-term fasting, a way to increase ketones acutely, has been demonstrated to speed up mitotic rates and thus facilitate a DNA damage sensitization. Lastly, a recent study showed that glucose restriction lowered Ki-67 expression, clonogenic frequency and rate of proliferation in gliomaspheres in vitro.
The investigating team team has an established expertise in conducting ketogenic diet interventions. Many individuals have adopted a low-carbohydrate diet for health reasons, yet there is scarce professional support available to provide guidance and support, especially for ketogenic diets. The investigators have scientific expertise and practical knowledge of both ketogenic and current standard of care cancer diets combined with a passion to empower people with the tools to implement these eating approaches into the participant's lifestyle. This project is highly patient-centered. The investigators will support patients who are randomized into either one of the intervention groups and provide them with a personalized eating plan designed to have maximal therapeutic impact and positively impact their lives. To that end, this project is unique in that it is highly patient-centered while also designed to have a substantial scientific and practical impact on medical management of brain metastasis treatments.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Laboratory Biomarker Analysis, Other: Neurocognitive Assessment, Other: Questionnaire Administration, Device: FitbitPatients receive standard of care therapy with SRS and AICR Diet education. |
| Standard of Care + Ketogenic Diet | Experimental | Other: Laboratory Biomarker Analysis, Other: Neurocognitive Assessment, Other: Questionnaire Administration, Device: Fitbit, Dietary Supplement: Dietary Intervention(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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative Studies | Other | Standard of Care, Standard of Care + Ketogenic Diet |
| Neurocognitive AssessmentNRG-CC | Other | Standard of Care, Standard of Care + Ketogenic Diet |
| Questionnaire AdministrationAncillary studies | Other | Standard of Care, Standard of Care + Ketogenic Diet |
| FitbitFitbit Activity Tracking | Device | Standard of Care, Standard of Care + Ketogenic Diet |
| Dietary InterventionUndergo ketogenic diet | Dietary supplement | Standard of Care + Ketogenic Diet |
Primary outcome
Feasibility of maintaining a ketogenic versus AICR diet in patients with brain metastasis selected for radiosurgery
Time frame: Up to 16 weeks
Summaries from questionnaires will be plotted over time to assess adherence and compliance to the ketogenic diet.
Feasibility of maintaining a ketogenic diet in patients with brain metastasis selected for radiosurgery
Time frame: Up to 16 weeks
Summaries from ketone logs will be plotted over time to assess adherence and compliance to the ketogenic diet.
Metabolic outcomes of a ketogenic versus AICR diet in patients with brain metastasis selected for radiosurgery
Time frame: Up to 16 weeks
Summaries from blood markers will be plotted over time to assess adherence and compliance to the ketogenic diet.
Number of Participants with partial-or-complete response according to RECIST v1.1
Time frame: Baseline up to 16 weeks
use a Chi-squared test for the association between treatment group and partial-or-complete response according to RECIST v1.1
3 secondary outcomes
Preliminary effects of the ketogenic versus AICR diet on Neurocognitive Function Scores in BM individuals undergoing radiation therapy
Time frame: 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
Time frame: 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
Time frame: Baseline up to 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- The JameslineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff Volek, PhD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laboratory Biomarker Analysis, Neurocognitive Assessment and Questionnaire Administration in people with Brain Metastases, Adult, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of maintaining a ketogenic versus AICR diet in patients with brain metastasis selected for radiosurgery (time frame: Up to 16 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.