search
Back to results

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

Primary Purpose

Glioblastoma Multiforme

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Keto Diet
Standard Anti-Cancer Diet
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring Keto Diet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Medical CenterRecruiting
  • University of California, San Francisco
  • Pacific Neuroscience Institute / Saint John's Cancer Institute
  • Duke University
  • Baylor Scott & White Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Keto-Diet

Standard Anti-Cancer Diet

Arm Description

Intensive 18-week Keto Diet intervention.

Standard Anti-Cancer Diet with Dietitian support

Outcomes

Primary Outcome Measures

Overall survival
Will be calculated as the number of days from the date of patient registration to the date of death.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
Physical activity
Measured by Fitbit data changes. The higher the step count the better the physical activity.

Full Information

First Posted
January 12, 2023
Last Updated
August 30, 2023
Sponsor
Cedars-Sinai Medical Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT05708352
Brief 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
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 27, 2023 (Actual)
Primary Completion Date
June 2028 (Anticipated)
Study Completion Date
June 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma Multiforme
Keywords
Keto Diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Keto-Diet
Arm Type
Experimental
Arm Description
Intensive 18-week Keto Diet intervention.
Arm Title
Standard Anti-Cancer Diet
Arm Type
Placebo Comparator
Arm Description
Standard Anti-Cancer Diet with Dietitian support
Intervention Type
Behavioral
Intervention Name(s)
Keto Diet
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Anti-Cancer Diet
Intervention 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.
Primary Outcome Measure Information:
Title
Overall survival
Description
Will be calculated as the number of days from the date of patient registration to the date of death.
Time Frame
From Baseline to 18 Months
Secondary Outcome Measure Information:
Title
Health-related quality of life 1
Description
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.
Time Frame
From Baseline to 18 Weeks
Title
Health-related quality of life 2
Description
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.
Time Frame
From Baseline to 18 Weeks
Title
Progression-free survival
Description
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.
Time Frame
From Baseline to 18 Weeks
Title
Cognitive performance 1
Description
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.
Time Frame
From Baseline to 18 Weeks
Title
Cognitive performance 2
Description
Measured by changes in the Trail Marking Test A/B survey scores. The longer the task takes to complete the lower the cognitive performance.
Time Frame
From Baseline to 18 Weeks
Title
Physical activity
Description
Measured by changes in the modified Godin leisure questionnaire survey scores. The more minutes per week spent in exercise the better the physical activity.
Time Frame
From Baseline to 18 Weeks
Title
Physical activity
Description
Measured by Fitbit data changes. The higher the step count the better the physical activity.
Time Frame
From Baseline to 18 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trial Recruitment Navigator
Phone
3104232133
Email
cancer.trial.info@cshs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jethro Hu, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Recruitment Navigator
Phone
310-423-2133
Email
cancer.trial.info@cshs.org
First Name & Middle Initial & Last Name & Degree
Jethro Hu
Phone
310 423 8100
Email
jethro.hu@cshs.org
First Name & Middle Initial & Last Name & Degree
Stephen Freedland, MD
First Name & Middle Initial & Last Name & Degree
Gillian Gresham, PhD
First Name & Middle Initial & Last Name & Degree
Mourad Tighiouart, PhD
First Name & Middle Initial & Last Name & Degree
Sungyong You, PhD
First Name & Middle Initial & Last Name & Degree
LJ Amaral, MS, RD, CSO
First Name & Middle Initial & Last Name & Degree
Jeremy Rudnick, MD
First Name & Middle Initial & Last Name & Degree
John Yu, MD
First Name & Middle Initial & Last Name & Degree
Chirag Patil, MD
First Name & Middle Initial & Last Name & Degree
Ray Chu, MD
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas Butowski, MD
Phone
415-353-2302
Email
Nicholas.butowski@ucsf.edu
Facility Name
Pacific Neuroscience Institute / Saint John's Cancer Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Santosh Kesari, MD, PhD
Phone
310-829-8265
Email
kesaris@jwci.org
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Peters, MD, PhD
Phone
919-684-5301
Email
katherine.peters@duke.edu
First Name & Middle Initial & Last Name & Degree
Lin Pao-Hwa, PhD
First Name & Middle Initial & Last Name & Degree
Jen-Tsan Chi, MD, PhD
Facility Name
Baylor Scott & White Health
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ekokobe Fonkem, DO
Phone
254-724-9786
Email
ekokobe.fonkem@BSWHealth.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs