Clinical trial NCT05708352: 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
Official title: A Randomized Controlled Phase 2 Study of the Ketogenic Diet Versus Standard Dietary Guidance for Patients With Newly Diagnosed Glioblastoma in Combination With Standard-of-care Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Glioblastoma Multiforme
Keywords: Keto Diet
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-02-01
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Adults 18 years or older
* Newly diagnosed glioblastoma (Within 2 months of initial diagnosis by histopathology)
* Not started standard of care chemotherapy and/or radiation therapy for glioblastoma
* Karnofsky Performance Status (KPS) ≥ 70
* Ability to read, write and understand either English OR Spanish
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

* Patients with recurrent glioblastoma
* Genetic disorders that affect lipid metabolism. Including but not limited to pyruvate carboxylase deficiency, porphyria, primary carnitine deficiency, carnitine palmitoyltransferase I or II deficiency, carnitine translocase deficiency, beta-oxidation defects
* Inability to wean steroids below 8mg dexamethasone / day or equivalent
* Body Mass Index (BMI) \< 21kg/m2, unless the site Principal Investigator deems safe
* Currently pregnant or nursing
* Patients receiving other experimental therapy Note: Off-label therapy use is permitted
* Comorbidities that in the opinion of the investigator limit the patient's ability to complete the study
* Food preferences incompatible with keto diet
* Using a pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implants (removable hearing aids permitted), or other electronic medical equipment, unless the site Principal Investigator deems safe
* Inability to participant in standard of care MRIs

Primary outcomes:
measure: Overall survival
timeFrame: From Baseline to 18 Months
Secondary outcomes:
measure: Health-related quality of life 1
timeFrame: From Baseline to 18 Weeks
measure: Health-related quality of life 2
timeFrame: From Baseline to 18 Weeks
measure: Progression-free survival
timeFrame: From Baseline to 18 Weeks
measure: Cognitive performance 1
timeFrame: From Baseline to 18 Weeks
measure: Cognitive performance 2
timeFrame: From Baseline to 18 Weeks
measure: Physical activity
timeFrame: From Baseline to 18 Weeks
measure: Physical activity
timeFrame: From Baseline to 18 Weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Santa Monica
country: United States
facility: Pacific Neuroscience Institute / Saint John's Cancer Institute
state: California
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Jethro Hu, MD
role: PRINCIPAL_INVESTIGATOR
References: