Ketogenic Diet With Radiation and Chemotherapy for Newly Diagnosed Glioblastoma

NCT02046187 | Terminated Phase 1 DMC

• 1 other identifier: KD-13BN069
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to see if reducing blood sugar and increasing ketones (a metabolic product that comes from using fats for energy) can increase survival and enhance the the effects of standard radiation and chemotherapy treatments used to treat glioblastoma multiforme (GBM). These changes occur from use of a ketogenic diet. This research has 2 goals:

1. 1.Show that patients can tolerate the diet and maintain low blood glucose and high blood ketone levels.
2. 2.Show if this diet enhances the effectiveness of standard treatment by prolonging survival of patients with a GBM.

Conditions

Glioblastoma (GBM)

Keywords

Ketogenic Diet; Brain tumor; Glioma; Glioblastoma; Radiation; Chemotherapy; temozolomide

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  Number of participants with adverse events from initiation of ketogenic diet through end of radiation (while on ketogenic diet)

  8 weeks

Secondary Outcomes (3)

• overall survival

  2 years

• time to progression

  2 years

• quality of life

  2 years

Study Arms (1)

Ketogenic Diet

EXPERIMENTAL

Subjects will adhere to a ketogenic diet prior to the start of and through radiation therapy course until the time of first scan after radiation ends. During radiation course, patients also take temozolomide daily.

Dietary Supplement: Ketogenic Diet; Radiation: Radiation therapy; Drug: Temozolomide

Interventions

Ketogenic Diet DIETARY_SUPPLEMENT

Patients/families meet with the study dietician after surgery to discuss the ketogenic diet (KD), ask questions and plan clinic visits. Before radiation and chemotherapy begins, training takes place about the diet, meal planning and ketone/glucose monitoring. Ketosis will begin with the help of the dietitian one week before radiation begins. The patient will follow a classic 4/1 KD during chemo-radiation, followed by a modified Atkins diet during monthly chemotherapy. At the end of this period patients will follow a normal low carbohydrate diet similar to a Diabetic diet. The dietitian will follow the patient over the course of treatment. The patient will take and record ketone and glucose blood levels daily from start to end of treatment MRI scan, and meet with the dietitian weekly during radiation, at follow-up visits and on an as-needed basis.

Ketogenic Diet

Radiation therapy RADIATION

Patients receive standard dose (60Gy/30 fractions) external beam radiation

Ketogenic Diet

Temozolomide DRUG

patients receive standard dose (75 mg/kg/day) temozolomide by mouth daily with radiation for 6 weeks. patients will also have standard maintenance dose (150-200 mg/kg/day) for five days each month for 12 cycles following radiation course.

Also known as: Temodar(R), chemotherapy

Ketogenic Diet

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients, 18 - 80 years of age,
• a single enhancing lesion of the brain with MRI appearance consistent with GBM
• Pathologic confirmation of GBM
• Zubrod Performance Scale (ZPS) \< 2
• Must be able to undergo MRI imaging with gadolinium
• Must have access to a computer and the internet (to use KetoCalculator© on-line Database)

You may not qualify if:

• unable to undergo MRI with gadolinium
• genetic disorders of fat metabolism
• patients receiving sodium valproate (may cause false ketone reading in urine)
• diabetes
• enrolled in another treatment trial for GBM

Sponsors & Collaborators

• St. Joseph's Hospital and Medical Center, Phoenix: lead

Study Sites (1)

Barrow Neurological Institute at St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

Related Publications (3)

• Abdelwahab MG, Fenton KE, Preul MC, Rho JM, Lynch A, Stafford P, Scheck AC. The ketogenic diet is an effective adjuvant to radiation therapy for the treatment of malignant glioma. PLoS One. 2012;7(5):e36197. doi: 10.1371/journal.pone.0036197. Epub 2012 May 1.

  PMID: 22563484 BACKGROUND

• Scheck AC, Abdelwahab MG, Fenton KE, Stafford P. The ketogenic diet for the treatment of glioma: insights from genetic profiling. Epilepsy Res. 2012 Jul;100(3):327-37. doi: 10.1016/j.eplepsyres.2011.09.022. Epub 2011 Oct 22.

  PMID: 22019313 BACKGROUND

• Stafford P, Abdelwahab MG, Kim DY, Preul MC, Rho JM, Scheck AC. The ketogenic diet reverses gene expression patterns and reduces reactive oxygen species levels when used as an adjuvant therapy for glioma. Nutr Metab (Lond). 2010 Sep 10;7:74. doi: 10.1186/1743-7075-7-74.

  PMID: 20831808 BACKGROUND

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms; Glioma

Interventions

Diet, Ketogenic; Radiotherapy; Temozolomide; Drug Therapy

Condition Hierarchy (Ancestors)

Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Adrienne C Scheck, PhD

  Barrow Neurological Research

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2014
• First Posted: January 27, 2014
• Study Start: October 1, 2013
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: June 16, 2021

Record last verified: 2021-06

Locations

US (1)