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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT05708352
Phase
PHASE2
Status
Recruiting
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Conditions

  • Glioblastoma Multiforme

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Keto Diet — BEHAVIORAL
    The experimental intervention includes a strict and controlled diet that manages daily macronutrient breakdown and increases the ratio of dietary fat relative to protein and carbohydrate consumption.
  • Standard Anti-Cancer Diet — BEHAVIORAL
    Dietitian sessions will utilize the American Institute for Cancer Research Food resources and will reference foods low in fats such as fruits, vegetables and whole grains, providing key micronutrients and phytonutrients. Sessions will also focus on dietary support to help decrease any treatment related symptoms.

Study Details

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.

Key Dates

Start date
Jun 27, 2023
Status verified
May 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2029

Study Design

Enrollment
170 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Keto-Diet
    Intensive 18-week Keto Diet intervention.
  • Placebo Comparator: Standard Anti-Cancer Diet
    Standard Anti-Cancer Diet with Dietitian support

Primary Outcome Measure

Overall survival [ Time Frame: From Baseline to 18 Months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Clinical Trial Recruitment Navigator
[email protected]
3104232133
Jethro Hu
[email protected]
310 423 8100
Stephen Freedland, MD (PRINCIPAL_INVESTIGATOR)
Gillian Gresham, PhD (SUB_INVESTIGATOR)
Mourad Tighiouart, PhD (SUB_INVESTIGATOR)
Sungyong You, PhD (SUB_INVESTIGATOR)
LJ Amaral, MS, RD, CSO (SUB_INVESTIGATOR)
Jeremy Rudnick, MD (SUB_INVESTIGATOR)
John Yu, MD (SUB_INVESTIGATOR)
Chirag Patil, MD (SUB_INVESTIGATOR)
Ray Chu, MD (SUB_INVESTIGATOR)
University of California, San FranciscoSan FranciscoCalifornia94143
Nicholas Butowski, MD
[email protected]
415-353-2302
Pacific Neuroscience Institute / Saint John's Cancer InstituteSanta MonicaCalifornia90404
Akanksha Sharma, MD
[email protected]
310-829-8265
Duke UniversityDurhamNorth Carolina27705
Katherine Peters, MD, PhD
[email protected]
919-684-5301
Lin Pao-Hwa, PhD (SUB_INVESTIGATOR)
Jen-Tsan Chi, MD, PhD (SUB_INVESTIGATOR)
Medical College of WisconsinMilwaukeeWisconsin53226-

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Cedars-Sinai Medical Center· Los Angeles, CAUniversity of California, San Francisco· San Francisco, CAPacific Neuroscience Institute / Saint John's Cancer Institute· Santa Monica, CADuke University· Durham, NCMedical College of Wisconsin· Milwaukee, WI

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