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A Phase 2 Study of the Ketogenic Diet vs Standard Anti-cancer Diet Guidance for Patients With Glioblastoma in Combination With Standard-of-care Treatment

StatusRecruiting
PhasePhase 2
Started2023-06-27
View on ClinicalTrials.gov ↗

Amendment history

2026-08-03
Study Status, Contacts/Locations v13
Study sitescontacts updated at 1 of 5 sites
2026-05-04
Study Status, Contacts/Locations v12
Study sitescontacts updated at 1 of 5 sites
2025-12-22
Study Status, Oversight, Contacts/Locations v11
Study sitesdetails revised at 1 of 5 sites
2025-06-13
Study Status, Oversight, Contacts/Locations v10
Study sitesdetails revised at 2 of 5 sites
2025-02-14
Study Identification, Study Status, Oversight, Contacts/Locations v9
Primary completion date2028-06→2028-09-30
Completion date2029-06→2029-09-30
Study sitescontacts updated at 2 of 5 sites
Study titlerevised
A Phase 2 Study of the Ketogenic Diet Vsvs Standard Anti-cancer Diet Guidance for Patients withWith Glioblastoma in Combination withWith Standard-of-care Treatment
Show 8 earlier versions
2025-02-03
Study Status v8
Re-verified, no change to tracked fields
2024-12-17
Study Identification, Study Status, Oversight, Contacts/Locations v7
Study sitesdetails revised at 2 of 5 sites
Study titlerevised
A Phase 2 Study of the Ketogenic Diet vsVs Standard Anti-cancer Diet Guidance for Patients Withwith Glioblastoma in Combination Withwith Standard-of-care Treatment
2024-06-14
Study Status, Contacts/Locations v6
Study sitesdetails revised at 1 of 5 sites
2024-02-28
Study Status, Contacts/Locations v5
Study sites5 entries, revised
BaylorMedical ScottCollege &of White HealthWisconsin
2024-02-05
Study Status v4
Re-verified, no change to tracked fields
2023-08-30
Not Yet Recruiting→Recruiting Study Identification, Study Status, Sponsor/Collaborators, Study Description, Arms and Interventions, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2028-04→2028-06
Completion date2029-04→2029-06
Start dateestimated 2023-06→confirmed 2023-06-27
InterventionsKeto Diet (Behavioral), Usual Diet (Behavioral)→Keto Diet (Behavioral), Standard Anti-Cancer Diet (Behavioral)
Study sitesdetails revised at 5 of 5 sites
Collaborators+31 characters
National Cancer Institute (NCI)
Study title+12 characters
A Phase 2 Study of the Ketogenic Diet vs Standard Anti-cancer Diet Guidance for Patients With Glioblastoma in Combination With Standard-of-care Treatment
2023-05-11
Study Identification, Study Status v2
Start date2023-04→2023-06
2023-01-31
Study Status, Study Design, Contacts/Locations v1
Study sitescontacts updated at 1 of 5 sites
2023-01-23
Original filing
This is a Phase 2, randomized two-armed, multi-site study of 170 patients with newly diagnosed glioblastoma multiforme. Patients will be randomized 1:1 to receive Keto Diet, or Standard Anti-Cancer Diet. All patients will receive standard of care treatment for their glioblastoma. The Keto Diet intervention will be for an 18-week period and conducted by trained research dietitians. Daily ketone and glucose levels will be recorded to monitor Keto Diet adherence. This two-armed randomized multi-site study aims to provide evidence to support the hypothesis that a Keto Diet vs. Standard Anti-Cancer Diet improves overall survival in newly diagnosed glioblastoma multiforme patients who receive standard of care treatment.
Trial Details
NCT Number NCT05708352
Lead Sponsor Cedars-Sinai Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions Glioblastoma Multiforme
Enrollment 170 participants
Start Date 2023-06-27
Primary Completion 2028-09-30 (estimated)
Study Completion 2029-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-05