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Keto Diet vs Standard Cancer Diet for Glioblastoma

Phase 2
Recruiting
Led By Jethro Hu, MD
Research Sponsored by Cedars-Sinai Medical Center
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 from baseline to 18 months

Summary

This trial is researching whether a Keto Diet could improve survival in glioblastoma patients.

Who is the study for?
This trial is for adults over 18 with newly diagnosed glioblastoma who haven't started chemotherapy or radiation. They must be able to perform daily activities well (KPS ≥ 70), read and understand English or Spanish, and commit to the study's requirements. Excluded are those with recurrent glioblastoma, certain genetic disorders, high steroid needs, pregnancy/nursing status, other experimental therapies, comorbidities that limit participation as per investigator's opinion, electronic medical implants unsafe for MRIs (with some exceptions), BMI < 21kg/m2 unless deemed safe by the investigator.
What is being tested?
The study compares two diets in patients with glioblastoma: a Keto Diet versus a Standard Anti-Cancer Diet. Each participant will also receive standard cancer treatments alongside their assigned diet. The Keto Diet group will have an 18-week intervention monitored by research dietitians through daily ketone and glucose level checks.
What are the potential side effects?
Potential side effects from the Keto Diet may include fatigue, constipation or diarrhea due to dietary changes, low blood sugar levels (hypoglycemia), nutrient deficiencies if not properly managed and possible increase in cholesterol levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall survival
Secondary study objectives
Cognitive performance 1
Cognitive performance 2
Health-related quality of life 1
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Keto-DietExperimental Treatment1 Intervention
Intensive 18-week Keto Diet intervention.
Group II: Standard Anti-Cancer DietPlacebo Group1 Intervention
Standard Anti-Cancer Diet with Dietitian support

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,111,947 Total Patients Enrolled
330 Trials studying Glioblastoma
23,217 Patients Enrolled for Glioblastoma
Cedars-Sinai Medical CenterLead Sponsor
513 Previous Clinical Trials
163,219 Total Patients Enrolled
5 Trials studying Glioblastoma
125 Patients Enrolled for Glioblastoma
Jethro Hu, MDPrincipal InvestigatorCedars-Sinai Medical Center
2 Previous Clinical Trials
60 Total Patients Enrolled
2 Trials studying Glioblastoma
60 Patients Enrolled for Glioblastoma

Media Library

Keto Diet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05708352 — Phase 2
Glioblastoma Research Study Groups: Standard Anti-Cancer Diet, Keto-Diet
Glioblastoma Clinical Trial 2023: Keto Diet Highlights & Side Effects. Trial Name: NCT05708352 — Phase 2
Keto Diet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05708352 — Phase 2
~113 spots leftby Jun 2028
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