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Ketogenic Diet for Pediatric Brain Cancer
N/A
Waitlist Available
Led By Daniel Bowers, MD
Research Sponsored by Daniel Bowers
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be < 21 years of age inclusive at the time of enrollment on this protocol
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, biologic therapy, or radiotherapy prior to entering this study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
Study Summary
This trial is testing whether a strict ketogenic diet can be implemented in children with brain tumors that have returned or progressed after treatment. If successful, this diet could be used to help these children manage their brain tumors.
Who is the study for?
This trial is for children under 21 with recurrent or progressive brain tumors that haven't responded to standard treatments. They must have recovered from previous therapies, not be on other cancer treatments, and able to follow a strict diet either by mouth or tube. Pregnant individuals or those with certain health conditions like diabetes treated with medication are excluded.Check my eligibility
What is being tested?
The study tests the feasibility of a strict classic ketogenic diet in young patients with tough-to-treat brain tumors. Participants will start the diet in the hospital for 5 days and continue at home for a year, keeping daily logs and attending regular check-ups.See study design
What are the potential side effects?
Potential side effects may include digestive issues due to dietary changes, low blood sugar levels, possible kidney stones if there's a history of them, and nutrient deficiencies without proper management.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 21 years old or younger.
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I have recovered from side effects of my previous cancer treatments.
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My brain tumor is growing or returning despite treatment.
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My tumor can be measured using specific imaging techniques.
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I can do most of my daily activities without help.
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I can eat by mouth or am willing to use a feeding tube if needed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility (safety and tolerability) of the ketogenic diet
Trial Design
1Treatment groups
Experimental Treatment
Group I: Strict Classic Ketogenic Diet ArmExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Daniel BowersLead Sponsor
University of Texas Southwestern Medical CenterLead Sponsor
1,047 Previous Clinical Trials
1,053,775 Total Patients Enrolled
Daniel Bowers, MDPrincipal InvestigatorUniversity of Texas Southwestern Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 21 years old or younger.You have a disorder that affects the breakdown of certain fats, as shown by a blood test.My bone marrow, kidneys, liver, lungs, and brain are working well.I have recovered from side effects of my previous cancer treatments.I am using effective birth control during the study.I haven't taken any growth factors in the last week.My brain tumor is growing or returning despite treatment.You are expected to live for more than 8 weeks.My tumor can be measured using specific imaging techniques.I can do most of my daily activities without help.I am being treated for diabetes with medication.I am not using any other cancer treatments or experimental therapies, except for multivitamins.I stopped taking systemic steroids more than 2 weeks ago, or 1 week ago if I have DIPG.I am not taking any chemotherapy or homeopathic drugs.I can eat by mouth or am willing to use a feeding tube if needed.I do not have any infections that aren't responding to treatment.I have had kidney stones in the past.I had a brain MRI with contrast within the last 2 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Strict Classic Ketogenic Diet Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there opportunities to join this research project still available?
"Clinicaltrials.gov indicates that this medical trial, which originally launched on October 1st 2022 and was last updated April 20th of the same year, is not currently seeking applicants. Nevertheless, there are still 1413 additional clinical trials searching for participants at present."
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