Strict Classic Ketogenic Diet as a Therapy for Recurrent or Progressive and Refractory Brain Tumors in Children
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|ClinicalTrials.gov Identifier: NCT03955068|
Recruitment Status : Not yet recruiting
First Posted : May 17, 2019
Last Update Posted : July 7, 2021
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Brain Tumor, Childhood Ketogenic Diet||Other: Strict Classic Ketogenic Diet||Not Applicable|
Primary Objective is to determine the feasibility (safety and tolerability) of a strict classic ketogenic diet among a population of children with recurrent or progressive and refractory brain tumors.
Secondary Objectives are: (1) to determine the objective response rate (complete response + partial response) to a strict classic ketogenic diet among children with recurrent or progressive and refractory brain tumor; (2) to estimate the time interval to tumor progression (Progression-Free Survival), time to treatment failure (Event-Free Survival), and time to death (Overall Survival) after initiation of a strict classic ketogenic diet among a group of pediatric patients with recurrent or progressive and refractory brain tumors; and (3) to describe and characterize tolerability and toxicities from a strict classic ketogenic diet among children with recurrent or progressive and refractory brain tumors.
Exploratory Objective: Identify biomarker correlates, including MR spectroscopy and metabolites of tumor response to a strict classic ketogenic diet.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of a Strict Classic Ketogenic Diet as a Therapy for Recurrent or Progressive and Refractory Brain Tumors in Children|
|Estimated Study Start Date :||January 2022|
|Estimated Primary Completion Date :||January 2024|
|Estimated Study Completion Date :||January 2024|
Strict Classic Ketogenic Diet Arm
The classic ketogenic diet is individually calculated for each patient based on age, weight, and nutritional needs. The diet is typically administered from a 2:1 to 4:1 ratio; this means 2 to 4 parts of fat to 1 part of both protein (calculated based on RDA and whatever remaining portion of carbohydrates. The basis of calculations is first on the amount of required protein needed to meet RDA to insure adequate growth. Fine tuning of ketogenic diet therapy is based on serum beta-hydroxybutyrate levels (target levels of 3.5-6.5 mmol/L), tolerance of the diet, and response to treatment.
Other: Strict Classic Ketogenic Diet
Diet is administered from a 2:1 to 4:1 ratio; this means 2 to 4 parts of fat to 1 part of both protein (calculated based on RDA and whatever remaining portion of carbohydrates.
- Feasibility (safety and tolerability) of the ketogenic diet [ Time Frame: 28 days ]Defined by the enrolled subject completing 28 days of ketogenic diet therapy without grade 3 - 5 adverse events. These will be assessed via NCI's CTCAE v5.0 toxicity criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03955068
|Contact: Daniel Bowers, MD||214-456-2382||Daniel.Bowers@UTSouthwestern.edu|
|United States, Texas|
|The University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75235|
|Principal Investigator:||Daniel Bowers, MD||University of Texas Southwestern Medical Center|