This pilot clinical trial studies the Glioma Atkins-based diet and how well it works in treating patients with grade II-IV astrocytoma. A new diet that is low in sugar and calories, called the Glioma Atkins-based Diet, which combines intermittent fasting with a low carbohydrate modified Adkins diet may be helpful in the management of brain tumors.
Additional locations may be listed on ClinicalTrials.gov for NCT02286167.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To assess feasibility of this diet in patients with high-grade astrocytoma.
SECONDARY OBJECTIVES:
I. Biologic activity, measured by pre-and post-study cerebral metabolite concentrations (i.e. choline, N-acetyl aspartate, glutamate, glutamine, etc) as assessed by magnetic resonance spectroscopy (MRS).
II. Tolerability, defined as the percent of patients who have an adverse reaction of any grade attributed to the diet of possible, probable, or definite.
III. Dietary activity, assessed by serial changes in serum glucose, ketones, weight trajectory, body fat composition, change in seizure frequency without anti-epileptic drug (AED) adjustment.
EXPLORATORY OBJECTIVES:
I. Time to progression.
II. Overall survival.
III. Metabolomics.
IV. Quality of life.
OUTLINE:
Patients follow the glioma-Atkins-based diet comprised of strict calorie restriction (to 20% of patient-specific recommended daily intake) for two non-consecutive "fasting" days interspersed evenly amongst five "non-fasting" days consisting of a modified Atkins diet (MAD). On "non-fasting" days, carbohydrate intake will be restricted to 20 grams according to standard MAD guidelines. All diets will be customized to the patient with the guidance of a registered dietician. Patients continue the diet for 8 weeks.
After completion of study, patients are followed up at week 8 and at 6 months.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorRoy Ervin Strowd