Enrolled subjects will be placed on a 16-week ketogenic diet (subject specific as prescribed by RD) while receiving standard of care cancer treatment (Radiation + Temozolomide). Study dietitians will create personalized meal plans for each patient with the goal of achieving and maintaining protocol defined metabolic ketosis. Subjects will be monitored for safety, nutrition, quality of life, and standard of care tumor assessments over the course of the study.
Enrolled subjects will be placed on a 16-week ketogenic diet (subject specific as prescribed by RD) while receiving standard of care cancer treatment (Radiation + Temozolomide). Study dietitians will place patients on a strict and controlled diet that manages daily macronutrient breakdown and increases the ratio of dietary fat relative to protein and carbohydrate consumption. Dietitians will provide guidance and teaching of the diet, as well as, monitoring and diet adjustment to ensure metabolic ketosis. Dietitians and study physicians (and their staff) will monitor subjects for safety, nutrition, quality of life, and standard of care tumor assessments over the course of the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
A 4-month ketogenic diet will be supervised and monitored by the study investigators. Study dietitians will create personalized meal plans for each patient with the goal of achieving and maintaining metabolic ketosis.
Patients will receive standard-of-care radiation. Radiation is not protocol directed.
Patients will receive standard-of-care temozolomide. Temozolomide is not protocol directed.
Cedars Sinai Medical Center
Los Angeles, California, United States
Safety of the intervention
Proportion of participants experiencing a 10% decrease in weight or body mass index AND have a BMI \<18.5 within one month from initiation of the ketogenic diet.
Time frame: Four Months
Safety of the intervention
Number of related adverse events based on CTCAE v.5.
Time frame: Four months
Feasibility of the intervention
Proportion of enrolled patients able to maintain blood ketone levels \>0.3 mM for over 50% of days on study starting 2 weeks after initiation of the ketogenic diet.
Time frame: Four Months
Overall Survival
Time (in months) from initiation of the ketogenic diet to date of death
Time frame: Sixty months
Time-to-progression
Time (in months) from baseline to progressive disease over study duration (estimated 4 months) \- measured by RANO criteria (standard of care brain MRI)
Time frame: Four Months
Quality of Life (two months)
Mean change in overall Quality of Life from baseline to two months. -Quality of Life measured using EORTC QLQ-C30 global score
Time frame: Two months
Quality of Life (four months)
Mean change in overall Quality of Life from baseline to four months. -Quality of Life measured using EORTC QLQ-C30 global score
Time frame: Four months
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Cognitive function (Hopkins Verbal Learning Test-Revised)
Mean change in cognitive function from initiation of ketogenic diet to four months. -measured using Hopkins Verbal learning Test-Revised
Time frame: Four months
Cognitive function (Trail Making Test)
Mean change in cognitive function from initiation of ketogenic diet to four months. -measured using Trail Making Test
Time frame: Four months
Cognitive function (Controlled Word Association Test)
Mean change in cognitive function from initiation of ketogenic diet to four months. -measured using Controlled Word Association Test
Time frame: Four months
Cognitive function (Montreal Cognitive Assessment)
Mean change in cognitive function from initiation of ketogenic diet to four months. -measured using Montreal Cognitive Assessment
Time frame: Four months