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ketogenic diet for Glioblastoma (KGDinGBM Trial)

Phase 1
Waitlist Available
Led By Pavel Klein, M.D.
Research Sponsored by Mid-Atlantic Epilepsy and Sleep Center, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights

Summary

This trial tests a high-fat, low-carbohydrate diet in patients with recurring or progressing brain tumors after standard treatments. The diet aims to starve the cancer cells of glucose while providing energy through ketones that normal brain cells can use. The goal is to see if this diet can help improve survival and reduce tumor growth. The ketogenic diet (KD) has been proposed as a metabolic treatment for high-grade gliomas, with early research suggesting it can control tumor growth and improve survival.

Eligible Conditions
  • Glioblastoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To evaluate the safety of ketogenic diet as adjunctive treatment of treatment-refractory glioblastoma multiforme.
Secondary outcome measures
Therapeutic procedure
To obtain pilot data on efficacy of ketogenic diet as adjunctive treatment of treatment-refractory glioblastoma multiforme

Trial Design

1Treatment groups
Experimental Treatment
Group I: ketogenic dietExperimental Treatment1 Intervention
Treatment will consist of ketogenic diet. KD will consist of 4:1 [fat] : [protein+carbohydrate] weight ratio with 1600 kcal restriction. The diet will be supplemented with vitamins, calcium, phosphorus, zinc and selenium supplements to meet the requirements of US Dietary Reference Intakes (DRI) standard.

Find a Location

Who is running the clinical trial?

Mid-Atlantic Epilepsy and Sleep Center, LLCLead Sponsor
8 Previous Clinical Trials
410 Total Patients Enrolled
1 Trials studying Glioblastoma
42 Patients Enrolled for Glioblastoma
University of Pittsburgh Medical CenterOTHER
70 Previous Clinical Trials
76,244 Total Patients Enrolled
Pavel Klein, M.D.Principal InvestigatorDirector Mid-Atlantic Epilepsy and Sleep Center
5 Previous Clinical Trials
338 Total Patients Enrolled
1 Trials studying Glioblastoma
42 Patients Enrolled for Glioblastoma
~0 spots leftby Sep 2025
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