Glioma Modified Atkins-based Diet in Patients With Glioblastoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2019-07-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ketogenic Diet With Radiation and Chemotherapy for Newly Diagnosed Glioblastoma

NCT02046187

Glioblastoma (GBM)

TERMINATED PHASE1/PHASE2

Ketogenic Diet Treatment Adjunctive to Radiation and Chemotherapy in Glioblastoma Multiforme: a Pilot Study

NCT02302235

Glioblastoma Multiforme of Brain

COMPLETED PHASE2

Ketogenic Diet in Combination With Standard-of-care Radiation and Temozolomide for Patients With Glioblastoma

NCT03451799

GBM Glioblastoma

ACTIVE_NOT_RECRUITING PHASE1

A Phase 2 Study of the Ketogenic Diet vs Standard Anti-cancer Diet Guidance for Patients With Glioblastoma in Combination With Standard-of-care Treatment

NCT05708352

Glioblastoma Multiforme

RECRUITING PHASE2

Calorie-restricted, Ketogenic Diet and Transient Fasting During Reirradiation for Patients With Recurrent Glioblastoma

NCT01754350

Recurrent Glioblastoma

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 utilization through glycolysis has been identified as a potential therapeutic target in cancer metabolism. Preclinically, reduced cerebral glucose via calorie restriction has been repeatedly associated with tumor reduction and improved survival in glioma animal models. Such work has led to several early clinical studies evaluating the ketogenic diet (KD) in patients with recurrent GBM.

The modified Atkins diet (MAD) is designed to provide a more palatable, less restrictive but effective alternative to the strict KD, particularly for adults. The MAD does not require inpatient admission for initial fast, weight of foods, or severe dietary restrictions and is generally well tolerated, easier to administer, and more practical for adults. The MAD lacks calorie restriction, an important component to dietary therapies in preclinical investigations. Emerging evidence also suggests that short term fasting may provide superior anti-cancer activity to long term calorie restriction and that these benefits have been observed without substantial weight loss that can be observed with longer term calorie restriction.

In glioma patients, a diet therapy that combines the broad clinical application of the MAD with the caloric impact of short-term intermittent fasting is therefore optimal. Moreover, initiation of this diet when the cancer has already undergone induction therapy and is clinically and radiographically stable, may provide the optimal time for metabolic intervention to prevent recurrence or progression.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glioblastoma Multiforme

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single arm diet

Intermittent, modified Atkins diet

Group Type OTHER

Diet modification

Intervention Type OTHER

All patients will be participate in the intermittent, modified Atkins diet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Diet modification

All patients will be participate in the intermittent, modified Atkins diet

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 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.
2. Karnofsky performance status \>/= 60.
3. Patients must be at least 18 years of age.

Exclusion Criteria

5. 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.

1. 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.
2. Severe acute infection.
3. BMI \> 35.0 or BMI \< 20.0.
4. Active bowel obstruction, ileus, or active or remote pancreatitis.
5. Clinically significant heart failure (NYHA \>2), recent myocardial infarction, or symptomatic atrial fibrillation.
6. Clinically significant renal disease (creatinine \>2.0 mg/dL, urea \>100 mg/dL).
7. Clinically significant hepatic dysfunction (alanine or aspartate aminotransferase \>7 times the upper limit of normal).
8. Patients with insulin-dependent diabetes mellitus.
9. Conditions that may increase the risk of the diet or significantly reduce compliance (i.e. cognitive impairment, frank dementia, etc).
10. Other concurrent experimental therapies.
11. Milk allergy.
12. Treatment with the modified Atkins diet (MAD) for any cause within the 9 months prior to study enrollment
13. Patient inability to complete baseline screening 3-day diet record.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No