Trial Title:
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
NCT ID:
NCT05708352
Condition:
Glioblastoma Multiforme
Conditions: Official terms:
Glioblastoma
Conditions: Keywords:
Keto Diet
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Keto Diet
Description:
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.
Arm group label:
Keto-Diet
Intervention type:
Behavioral
Intervention name:
Standard Anti-Cancer Diet
Description:
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.
Arm group label:
Standard Anti-Cancer Diet
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cedars-Sinai Medical Center
Address:
City:
Los Angeles
Zip:
90048
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trial Recruitment Navigator
Phone:
310-423-2133
Email:
cancer.trial.info@cshs.org
Contact backup:
Last name:
Jethro Hu
Phone:
310 423 8100
Email:
jethro.hu@cshs.org
Investigator:
Last name:
Stephen Freedland, MD
Email:
Principal Investigator
Investigator:
Last name:
Gillian Gresham, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Mourad Tighiouart, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Sungyong You, PhD
Email:
Sub-Investigator
Investigator:
Last name:
LJ Amaral, MS, RD, CSO
Email:
Sub-Investigator
Investigator:
Last name:
Jeremy Rudnick, MD
Email:
Sub-Investigator
Investigator:
Last name:
John Yu, MD
Email:
Sub-Investigator
Investigator:
Last name:
Chirag Patil, MD
Email:
Sub-Investigator
Investigator:
Last name:
Ray Chu, MD
Email:
Sub-Investigator
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nicholas Butowski, MD
Phone:
415-353-2302
Email:
Nicholas.butowski@ucsf.edu
Facility:
Name:
Pacific Neuroscience Institute / Saint John's Cancer Institute
Address:
City:
Santa Monica
Zip:
90404
Country:
United States
Status:
Recruiting
Contact:
Last name:
Akanksha Sharma, MD
Phone:
310-829-8265
Email:
Akanksha.Sharma@providence.org
Facility:
Name:
Duke University
Address:
City:
Durham
Zip:
27705
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Katherine Peters, MD, PhD
Phone:
919-684-5301
Email:
katherine.peters@duke.edu
Investigator:
Last name:
Lin Pao-Hwa, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Jen-Tsan Chi, MD, PhD
Email:
Sub-Investigator
Facility:
Name:
Medical College of Wisconsin
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Ekokobe Fonkem, DO
Email:
efonkem@mcw.edu
Start date:
June 27, 2023
Completion date:
June 2029
Lead sponsor:
Agency:
Cedars-Sinai Medical Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Cedars-Sinai Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05708352
