Glioma Modified Atkins-based Diet in Patients With Glioblastoma (NCT02286167) | Clinical Trial Compass
CompletedNot Applicable
Glioma Modified Atkins-based Diet in Patients With Glioblastoma
United States25 participantsStarted 2014-11
Plain-language 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 patients with central nervous system GBM.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
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.
✕. 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.
Feasibility of intermittent modified Atkins diet in patients with GBM assessed by percent of patients able to remain on the diet and achieve nutritional goals