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NCT05708352 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Glioblastoma Multiforme, sponsored by Cedars-Sinai Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 170
- Enrollment target
- 5
- Study locations
NCT05708352: Recruiting Phase 2 study of Glioblastoma Multiforme, sponsored by Cedars-Sinai Medical Center.
NCT05708352 is a Phase 2 study of Glioblastoma Multiforme that is actively recruiting participants, run by Cedars-Sinai Medical Center. The registered enrollment target is 170 participants, above the 95-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (79% higher). The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05708352, a Phase 2 study of Glioblastoma Multiforme, is actively recruiting participants, sponsored by Cedars-Sinai Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 170 participants
- Enrollment target
- 5
- Study locations
Study Summary
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.
Primary Outcome
Will be calculated as the number of days from the date of patient registration to the date of death.
Conditions Studied
Interventions
- BEHAVIORAL Standard Anti-Cancer Diet
- BEHAVIORAL Keto Diet
Study Locations (5)
California
- Cedars-Sinai Medical Center - Los Angeles
- University of California, San Francisco - San Francisco
- Pacific Neuroscience Institute / Saint John's Cancer Institute - Santa Monica
North Carolina
- Duke University - Durham
Wisconsin
- Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2023-06-27 |
| Est. Completion | 2029-09-30 |
| Phase | Phase 2 |
What NCT05708352 shows while recruiting
NCT05708352 is an interventional study that assigns participants to a tested intervention. The registered 170 participants enrollment target is mid-sized for trials with a published cap, above the 95-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (79% higher).
The record links to 1 condition, with Glioblastoma Multiforme appearing as the primary indexed condition, and to 2 interventions - of which Standard Anti-Cancer Diet is the first listed.
NCT05708352 lists 5 locations in 3 states (California, North Carolina, Wisconsin).
Frequently Asked Questions
What is clinical trial NCT05708352 about?
NCT05708352 is a clinical study titled "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". 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 inter...
What is the current status of trial NCT05708352?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 170 participants. The study started on 2023-06-27. Estimated completion is 2029-09-30.
What conditions does trial NCT05708352 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme.
What interventions are being tested in trial NCT05708352?
The interventions under investigation include: Standard Anti-Cancer Diet (BEHAVIORAL), Keto Diet (BEHAVIORAL).
Who is sponsoring clinical trial NCT05708352?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05708352 being conducted?
This trial has 5 study locations across California, North Carolina, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05708352's enrollment target sits among peer trials
170 11th of 88 higher than 78 of 88 other Glioblastoma Multiforme trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma Multiforme trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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