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A Ketogenic Diet in Combination with Standard-of-Care Therapy for the Treatment of Patients with Newly Diagnosed Glioblastoma, The DIET2TREAT Study
Trial Status: active
This clinical trial compares the effect of consuming a ketogenic diet versus (vs) a usual diet, in combination with standard-of-care (SOC) treatment, in patients newly diagnosed with glioblastoma (GBM). A ketogenic diet is a high fat, moderate protein, low carbohydrate diet. Preclinical work (work done before studies with humans) has shown that a high-fat / low-carbohydrate diet can slow cancer growth. GBM, similar to many cancers shows altered glucose uptake and metabolism. By limiting the changes in how glucose is processed and modifying metabolism, the Keto Diet (KD) may have anti-cancer effects. The KD may stop abnormal insulin-PI3K signaling (note: PI3K controls a cell’s metabolism and cell decisions, including cell survival and growth), may make the environment less inviting for inflammation and tumors, and may encourage an anti-tumor immune response in newly diagnosed GBM patients.
Inclusion Criteria
Adults 18 years or older
Newly diagnosed GBM (within 2 months of initial diagnosis by histopathology)
Not started standard of care chemotherapy and/or radiation therapy for GBM
Karnofsky Performance Status (KPS) >= 70
Ability to read, write and understand either English OR Spanish
Access to a smart device that has the capacity to download app’s and sync to the study devices
Written informed consent obtained from subject and ability for subject to comply with the requirements of the study
Exclusion Criteria
Patients with recurrent GBM
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/m^2, unless the site Principal Investigator (PI) 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 KD
Using a pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implants (removable hearing aids permitted), or other electronic medical equipment, unless the site PI deems safe
Inability to participant in SOC MRIs
Additional locations may be listed on ClinicalTrials.gov for NCT05708352.
I. To assess clinical efficacy of an 18-week ketogenic diet on overall survival measured at 18 months post intervention.
SECONDARY OBJECTIVES:
I. To assess quality of life.
II. To assess progression free survival.
III. To assess cognitive performance.
IV. To assess physical activity.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients consume their usual diet, undergo blood, tissue and stool sample collection, wear a fitbit device, and use an Aria smart scale on study.
ARM II: Patients consume a KD, undergo blood, tissue and stool sample collection, wear a fitbit device, use an Aria smart scale, and use a keto-mojo device on study.
Patients will be assessed at 18 months post week 1 visit date and every 1 year thereafter until death, loss to follow-up, or until study is closed, whichever occurs first, for a maximum of 3 years.
