Ketogenic Diet With Radiation and Chemotherapy for Newly Diagnosed Glioblastoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by St. Joseph's Hospital and Medical Center, Phoenix
Sponsor:
Information provided by (Responsible Party):
St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier:
NCT02046187
First received: January 17, 2014
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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

Condition Intervention Phase
Glioblastoma (GBM)
Dietary Supplement: Ketogenic Diet
Radiation: Radiation therapy
Drug: Temozolomide
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Prospective Trial for Newly Diagnosed GBM, With Upfront Gross or Subtotal Resection, Followed by Ketogenic Diet With Radiotherapy and Concurrent Temodar(R) Chemotherapy Followed by Adjuvant Temodar(R) Chemotherapy.

Resource links provided by NLM:


Further study details as provided by St. Joseph's Hospital and Medical Center, Phoenix:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events from initiation of ketogenic diet through end of radiation (while on ketogenic diet)


Secondary Outcome Measures:
  • overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • time to progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ketogenic Diet
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
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.
Radiation: Radiation therapy
Patients receive standard dose (60Gy/30 fractions) external beam radiation
Drug: Temozolomide
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.
Other Names:
  • Temodar(R)
  • chemotherapy

Detailed Description:

The investigators propose to offer this study to patients with newly diagnosed glioblastoma multiforme (GBM) that undergo gross total resection (GTR) or subtotal resection (STR) of their tumor. Post-operatively, these patients and their families will be instructed in the implementation of the Ketogenic Diet (KD) and it will be started as soon as possible following surgery to achieve ketosis and reduction of blood sugar. Patients will receive standard chemoradiotherapy with fractionated external beam radiation (60Gy) and concurrent oral temozolomide chemotherapy followed by 12 adjuvant cycles of temozolomide chemotherapy on a standard dose schedule. Outcome measures of the study group will be compared to historic controls in the treatment arm from the European Organization for Research and Treatment of Cancer (EORTC) temozolomide study published by Roger Stupp et al, New England Journal of Medicine, March 10, 2005.

Note: Gross Total Resection (GTR), Subtotal Resection (STR), temozolomide (Temodar), and radiation therapy are routine care for GBM and are not an investigational component of this study.

Study end-points:

Primary: Ketogenic diet (KD) tolerance and compliance in brain tumor patients. The diet will be considered tolerable if the patient chooses to remain compliant. Compliance is monitored by the dietician using self reporting of diet, blood glucose and blood ketone levels.

Secondary: Overall survival, time to recurrence, health and therapy-related quality of life. Overall survival and progression free survival will be measured and compared to the historic controls who received chemoradiotherapy in standard dose scheduling.

Laboratory correlate: Molecular/immunohistochemical analysis of tumors that do and do not respond to a KD.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  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: NCT02046187

Locations
United States, Arizona
Barrow Neurological Institute at St. Joseph's Hospital and Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Contact: Norissa Honea, PhD, RN    602-406-6267    Norissa.Honea@dignityhealth.org   
Contact: Leonora Renda, RD    602-406-4658    Leonora.Renda@dignityhealth.org   
Principal Investigator: Lynn S Ashby, MD         
Principal Investigator: Adrienne C Scheck, PhD         
Sub-Investigator: Norissa Honea, PhD, RN         
Sub-Investigator: Leonora Renda, RD         
Sponsors and Collaborators
St. Joseph's Hospital and Medical Center, Phoenix
Investigators
Study Chair: Adrienne C Scheck, PhD Barrow Neurological Research
  More Information

Publications:
Responsible Party: St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier: NCT02046187     History of Changes
Other Study ID Numbers: KD-13BN069
Study First Received: January 17, 2014
Last Updated: July 28, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by St. Joseph's Hospital and Medical Center, Phoenix:
Ketogenic Diet
Brain tumor
Glioma
Glioblastoma
Radiation
Chemotherapy
temozolomide

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Temozolomide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014