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Glioma Modified Atkins-based Diet in Patients With Glioblastoma (GLAD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Wake Forest University Health Sciences
Sponsor:
Collaborator:
Sidney Kimmel Comprehensive Cancer Center
Information provided by (Responsible Party):
Roy Strowd, MD, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT02286167
First received: November 5, 2014
Last updated: October 26, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention
Glioblastoma Multiforme
Other: Diet modification

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: The Feasibility and Biologic Effect of a Modified Atkins-based Intermittent Fasting Diet in Patients With Glioblastoma (GBM)

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • 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 [ Time Frame: 8 weeks per patient ]
    Percent of patients able to remain on the diet and achieve nutritional goals as defined by cumulative assessment of diet records collected at weeks 4, 6, and 8 with a 60% completion defined as a positive results


Secondary Outcome Measures:
  • Biologic activity measured by pre- and post-study cerebral glutamate and glutamine concentrations assessed by MRS. [ Time Frame: 8 weeks per patient ]
    Measured by pre- and post-study cerebral glutamate and glutamine concentrations assessed by MRS.

  • Tolerability assessed by percent of patients who have an adverse reaction of any grade attributed to the diet of possible, probable, or definite [ Time Frame: 8 weeks per patient ]
    Percent of patients who have an adverse reaction of any grade attributed to the diet of possible, probable, or definite

  • Dietary Activity [ Time Frame: 8 weeks per patient ]
    Dietary compliance will be assessed by serial changes in serum glucose, ketones, weight trajectory, body fat composition, change in seizure frequency without AED adjustment


Estimated Enrollment: 25
Study Start Date: November 2014
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single arm diet
Intermittent, modified Atkins diet
Other: Diet modification
All patients will be participate in the intermittent, modified Atkins diet

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  4. 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).
  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.

Exclusion Criteria:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02286167

Contacts
Contact: Roy E. Strowd, MD 336-716-7422 rstrowd@wakehealth.edu
Contact: Sandra Norona 336-716-7422 snorona@wakehealth.edu

Locations
United States, Maryland
The Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Roy E Strowd, MD       rstrowd@wakehealth.edu   
Contact: Lindsay K Blair, CRNP    (410) 955-8009    lblair1@jhmi.edu   
United States, North Carolina
Wake Forest School of Medicine Recruiting
Winston Salem, North Carolina, United States, 27157
Contact: Roy Strowd, MD       rstrowd@wakehealth.edu   
Contact: Sandra Norona       snorona@wakehealth.edu   
Sponsors and Collaborators
Wake Forest University Health Sciences
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Jaishri O. Blakeley, MD Johns Hopkins University
  More Information

Responsible Party: Roy Strowd, MD, Assistant Professor of Neurology and Internal Medicine, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT02286167     History of Changes
Other Study ID Numbers: J1444 NA_00093542
Study First Received: November 5, 2014
Last Updated: October 26, 2016

Keywords provided by Wake Forest University Health Sciences:
modified-Atkins diet
ketogenic diet
central nervous system malignancy
glioma

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on April 26, 2017