Pilot Study of a GLioma Atkins-based Diet (GLAD) in Patients with High-Grade Astrocytoma Comprehensive Cancer Center of Wake Forest University

What we are studying

The purpose of this research study is to learn more about the diet therapies in treating people with brain tumors. The purpose of this research is to determine whether a new diet that is low in sugar and calories called the GLAD diet (GLioma Atkins-based Diet) is safe and feasible in people with brain tumors. This diet is a Modified Atkins Diet, which limits the number of carbohydrates that can be eaten each day combined with short periods of fasting.

Who we are studying

  • Men and Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Patients must have a clinical and histopathologic diagnosis of high-grade astrocytoma (WHO
  • Grade III or IV astrocytoma)
  • Must have completed >80% of prescribed concurrent chemoradiotherapy without CTCEA grade 4 toxicities
  • Must be greater than 7 months from the time of completion of concurrent chemoradiotherapy with stable disease by neuroimaging
  • Must be eligible to undergo a ketogenic or Atkins based diet according to:
    • Baseline body mass index
  • Comorbid medical conditions and laboratory assessments
  • Must be of appropriate mental capacities with sufficient social support so as to be able to complete required study activities (i.e. diet record; etc). Patients cannot have been treated with the modified Atkins diet (MAD) for any cause within the 9 months prior to study enrollment
  • Cannot have active bowel obstruction; ileus; or active or remote pancreatitis
  • Cannot have significant hear; renal; liver disease; insulin-dependent diabetes or milk allergy.

What is involved

  • You will have 2 MRI Spectroscopy scans: one before you start the study diet and one at the end of the study diet
  • You will be asked to complete a baseline screening 3-day diet record before starting the study diet
  • You will have 5 visits at the (CRU) clinical research unit (every 2 weeks for 8 weeks) where you will:
  • Meet with the study dietitian
  • Have your vitals collected
  • Have (fasting) blood drawn
  • Have urine collected
  • Complete questionnaires and review your medical history; medications and seizure diary.
  • The study doctor will also perform a medical and neurological evaluation at the first third and last study visits
  • While you are following the study diet you will be asked to keep a diary to record your dietary intake; weight; seizures and results of home urine ketone testing
  • You will also be contacted 6 months after your Week 8 (End of Study Visit) and you will be asked follow up questions.

Compensation

None

Contact Information

Study Coordinator
Sandra Norona
Email
snorona@wakehealth.edu
Phone
336-716-0308
Principal Investigator
Roy Strowd, MD

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.