Ketogenic Diet with Standard Treatment for Newly Diagnosed GBM (Glioblastoma)

Purpose of this Study

We are doing this study to compare a ketogenic diet (a diet with high fat, moderate protein, very low carbohydrate) versus a normal diet. We want to find out if it has any effect on survival time for people with glioblastoma multiforme (GBM). We also want to know how biomarkers change when people follow a ketogenic diet. A biomarker is a biological molecule found in blood, other body fluids, or tissues. Biomarkers may be a sign of a condition or disease and can be used to predict someone's response to a specific treatment.

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Have newly diagnosed GBM (Within 2 months of initial diagnosis by histopathology)
  • Have NOT started standard of care chemotherapy and/or radiation therapy for GBM
  • Have access to a smart device that has the capacity to download apps and sync to the study devices
  • Do not have any genetic disorders that affect lipid metabolism
For more information about who can be in this study, please contact the study team at 919-684-5301.

Age Range

18-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

If you choose to join the study, it will involve following an assigned diet for 18 weeks, a follow-up with our team at 18-months after the diet ends, and a follow-up with the study team every year for the next 3 years. Before beginning the 18 weeks of the diet, you will get a random assignment (like a coin flip) to 1 of 2 diets:
  • A ketogenic diet; OR
  • A usual diet following the American Cancer Society Guidelines of Diet and Physical Activity
During the 18 weeks of the diet you will:
  • Have weekly or bi-weekly meetings with a dietitian
  • Have blood draws and give stool samples
  • Have imaging scans (MRI)
  • Wear a Fitbit device to continuously monitor your physical activity and sleep
  • Weigh yourself weekly
  • Use an at home Keto-Mojo device daily to collect a drop of blood and monitor your ketone and glucose levels (this only applies to people assigned to follow a ketogenic diet)
About 7 days after you finish the study diet, you will have an end-of-study visit to see how you are doing. At that visit you will:
  • Meet with a dietitian
  • Have blood draws and give a stool sample
  • Have an imaging scan (MRI)
  • Provide a final drop of blood to measure your ketone and glucose levels (participants assigned to the ketogenic diet only)
About 18 months after that visit, someone from the study team will contact you to see how you are doing. Your doctor will continue to follow your condition every year for the next 3 years. Your doctor may do this by a phone call or by reviewing your medical records.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

No

Study Details

Full 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

Principal Investigator

Katherine
Peters

Protocol Number

PRO00108622

NCT ID

NCT05708352

Phase

II

Enrollment Status

Open to Enrollment
ClinicalTrials.gov