Dietary Intervention for Brain Metastases, Adult

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Ohio State University Comprehensive Cancer Center, Columbus, OH
Brain Metastases, Adult+2 More
Dietary Intervention - DietarySupplement
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Brain Metastases, Adult

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Brain Metastases, Adult

Study Objectives

4 Primary · 3 Secondary · Reporting Duration: Up to 16 weeks

Week 16
Number of Participants with partial-or-complete response according to RECIST v1.1
Preliminary effects of the ketogenic versus AICR diet on Heart Hope Scale in BM individuals undergoing radiation therapy to asses quality of life
Preliminary effects of the ketogenic versus AICR diet on Neurocognitive Function Scores in BM individuals undergoing radiation therapy
Preliminary effects of the ketogenic versus AICR diet on PROMIS Cognitive Function Short Form 8a Scores in BM individuals undergoing radiation therapy
Up to 16 weeks
Feasibility of maintaining a ketogenic diet in patients with brain metastasis selected for radiosurgery
Feasibility of maintaining a ketogenic versus AICR diet in patients with brain metastasis selected for radiosurgery
Metabolic outcomes of a ketogenic versus AICR diet in patients with brain metastasis selected for radiosurgery

Trial Safety

Safety Progress

1 of 3

Other trials for Brain Metastases, Adult

Trial Design

2 Treatment Groups

Standard of Care
1 of 2
Standard of Care + Ketogenic Diet
1 of 2
Active Control
Experimental Treatment

24 Total Participants · 2 Treatment Groups

Primary Treatment: Dietary Intervention · No Placebo Group · N/A

Standard of Care + Ketogenic DietExperimental Group · 5 Interventions: Laboratory Biomarker Analysis, Dietary Intervention, Fitbit, Questionnaire Administration, Neurocognitive Assessment · Intervention Types: Other, DietarySupplement, Device, Other, Other
Standard of CareActiveComparator Group · 4 Interventions: Laboratory Biomarker Analysis, Fitbit, Questionnaire Administration, Neurocognitive Assessment · Intervention Types: Other, Device, Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dietary Intervention
2014
Completed Phase 2
~2550
Fitbit
2018
N/A
~3440

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 16 weeks

Trial Background

Prof. Jeff Volek, Professor
Principal Investigator
Ohio State University Comprehensive Cancer Center
Closest Location: Ohio State University Comprehensive Cancer Center · Columbus, OH
Photo of Columbus  1Photo of Columbus  2Photo of Columbus  3
2011First Recorded Clinical Trial
1 TrialsResearching Brain Metastases, Adult
203 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have measurable brain lesions on baseline MRI imaging.
You have a body mass index (BMI) of 18 or more.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.