Status:
COMPLETED
Glioma Modified Atkins-based Diet in Patients With Glioblastoma
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary goal of this study is to assess the feasibility and biologic activity of a modified Atkins-based diet combined with short-term intermittent fasting, a GLioma Atkins-based Diet (GLAD), in p...
Detailed Description
Malignant gliomas have a high glycolytic rate and are dependent on glucose for energy metabolism. This so called "Warburg effect" or the reliance of central nervous system (CNS) tumor cells on glucose...
Eligibility Criteria
Inclusion
- Patients must have a clinical and histopathologic diagnosis of GBM, have completed \>80% of prescribed concurrent radiation therapy and adjuvant temozolomide without CTCEA grade 3 or 4 toxicity, and be greater than 7 months from the time of completion of concurrent chemoradiotherapy.
- Karnofsky performance status \>/= 60.
- Patients must be at least 18 years of age.
- Patients must be eligible to undergo a ketogenic or Atkins based diet according to baseline body mass index (BMI, see exclusion criteria), comorbid medical conditions (see exclusion criteria), and baseline laboratory assessment (see exclusion criteria).
- Patients 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) and able to provide written informed consent.
Exclusion
- Patients with a history of a metabolic disorder including documented defect in urea metabolism (including documented history of gout), carnitine deficiency (primary carnitine deficiency, carnitine palmitoyltransferase I or II deficiency, carnitine translocase deficiency), fatty acid metabolism, beta-oxidation defects, pyruvate carboxylase deficiency, mitochondrial function, porphyria, or nephrolithiasis.
- Severe acute infection.
- BMI \> 35.0 or BMI \< 20.0.
- Active bowel obstruction, ileus, or active or remote pancreatitis.
- Clinically significant heart failure (NYHA \>2), recent myocardial infarction, or symptomatic atrial fibrillation.
- Clinically significant renal disease (creatinine \>2.0 mg/dL, urea \>100 mg/dL).
- Clinically significant hepatic dysfunction (alanine or aspartate aminotransferase \>7 times the upper limit of normal).
- Patients with insulin-dependent diabetes mellitus.
- Conditions that may increase the risk of the diet or significantly reduce compliance (i.e. cognitive impairment, frank dementia, etc).
- Other concurrent experimental therapies.
- Milk allergy.
- Treatment with the modified Atkins diet (MAD) for any cause within the 9 months prior to study enrollment
- Patient inability to complete baseline screening 3-day diet record.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2019
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT02286167
Start Date
November 1 2014
End Date
July 12 2019
Last Update
May 12 2020
Active Locations (2)
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1
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
2
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27157