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Ketogenic Diet + Radiation & Chemotherapy for Glioblastoma
Phase 1
Waitlist Available
Led By Jethro Hu, MD
Research Sponsored by Jethro Hu
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Patients currently receiving experimental therapeutic therapy will be excluded from the trial. Note: Off-label therapy use is permitted
Patients with disorders that affect lipid metabolism such as pyruvate carboxylase deficiency, porphyria, primary carnitine deficiency, carnitine palmitoyltransferase I or II deficiency, carnitine translocase deficiency, Beta-Oxidation Defects
Timeline
Screening 3 weeks
Treatment Varies
Follow Up four months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether a ketogenic diet can help treat cancer alongside standard radiation and chemotherapy.
Who is the study for?
Adults over 18 with newly diagnosed glioblastoma can join this trial if they're being treated at Cedars-Sinai Medical Center or elsewhere for chemotherapy/radiation. They must be able to follow a ketogenic diet, have a BMI of ≥22, and be on low doses of steroids. Excluded are those with certain medical conditions, high steroid doses, vegan/vegetarian diets, allergies to specific materials used in the study tools, and incompatible implants.
What is being tested?
The trial tests how well patients with glioblastoma respond to a personalized 16-week ketogenic diet while undergoing standard cancer treatments like radiation and Temozolomide. Dietitians will tailor meal plans aiming for metabolic ketosis. Patient safety, nutrition levels, life quality, and tumor response are monitored throughout.
What are the potential side effects?
Potential side effects from the ketogenic diet may include fatigue, constipation or diarrhea due to dietary changes. Standard-of-care radiation might cause skin irritation or hair loss at the treatment site; Temozolomide could lead to nausea/vomiting, headaches or blood-related issues.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not on any experimental drugs for my condition.
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I have a condition that affects how my body processes fats.
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I am not on high doses of steroids.
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I am not vegan or vegetarian.
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I am allergic to certain dyes used in medical scans.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ four months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~four months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety of the intervention
Secondary study objectives
Cognitive function (Controlled Word Association Test)
Cognitive function (Hopkins Verbal Learning Test-Revised)
Cognitive function (Montreal Cognitive Assessment)
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ketogenic diet+radiation+temozolomideExperimental Treatment3 Interventions
Ketogenic diet in combination with standard-of-care radiation and standard-of-care temozolomide
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Who is running the clinical trial?
Jethro HuLead Sponsor
Jethro Hu, MDPrincipal InvestigatorCedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute
2 Previous Clinical Trials
209 Total Patients Enrolled
2 Trials studying Glioblastoma
209 Patients Enrolled for Glioblastoma
Media Library
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.