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

Glioblastoma Multiforme Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05708352
• Other study ID #: IIT2022-06-HU-DIET2TREAT
• Secondary ID: R01CA276919
• Status: Recruiting
• Phase: Phase 2
• Start date: June 27, 2023
• Est. completion date: June 2029

Study information

• Verified date: June 2024
• Source: Cedars-Sinai Medical Center
• Contact: Clinical Trial Recruitment Navigator
• Phone: 3104232133
• Email: cancer.trial.info[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: June 2029
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Behavioral:
• Keto Diet
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
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.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of California, San Francisco	San Francisco	California
United States	Pacific Neuroscience Institute / Saint John's Cancer Institute	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Will be calculated as the number of days from the date of patient registration to the date of death.	From Baseline to 18 Months
Secondary	Health-related quality of life 1	Measured by changes in the Functional Assessment of Cancer Therapy - Brain (FACT-BR) survey scores. Scores can range from 0- 200, the higher the score the better the quality of life.	From Baseline to 18 Weeks
Secondary	Health-related quality of life 2	Measured by changes in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) survey scores. Scores can range from 0- 160, the higher the score the better the quality of life.	From Baseline to 18 Weeks
Secondary	Progression-free survival	Assessed with Magnetic resonance imaging (MRI) scan of the brain with and without gadolinium. MRI's will be reviewed and assessed for progression free survival via the modified Response Assessment in Neuro-Oncology Criteria.	From Baseline to 18 Weeks
Secondary	Cognitive performance 1	Measured by changes in the Hopkins Verbal Test (HVLT-R) survey scores. Scores can range from 0-36, higher the scores the better the cognitive performance.	From Baseline to 18 Weeks
Secondary	Cognitive performance 2	Measured by changes in the Trail Marking Test A/B survey scores. The longer the task takes to complete the lower the cognitive performance.	From Baseline to 18 Weeks
Secondary	Physical activity	Measured by changes in the modified Godin leisure questionnaire survey scores. The more minutes per week spent in exercise the better the physical activity.	From Baseline to 18 Weeks
Secondary	Physical activity	Measured by Fitbit data changes. The higher the step count the better the physical activity.	From Baseline to 18 Weeks