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Ketogenic Diet With Radiation and Chemotherapy for Newly Diagnosed Glioblastoma

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ClinicalTrials.gov Identifier: NCT02046187
Recruitment Status : Terminated (excessive protocol deviations due to strict nature of diet requirements)
First Posted : January 27, 2014
Last Update Posted : June 16, 2021
Sponsor:
Information provided by (Responsible Party):
St. Joseph's Hospital and Medical Center, Phoenix

Tracking Information
First Submitted Date  ICMJE January 17, 2014
First Posted Date  ICMJE January 27, 2014
Last Update Posted Date June 16, 2021
Actual Study Start Date  ICMJE October 2013
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2014)
Number of participants with adverse events [ Time Frame: 8 weeks ]
Number of participants with adverse events from initiation of ketogenic diet through end of radiation (while on ketogenic diet)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2021)
  • overall survival [ Time Frame: 2 years ]
    overall survival
  • time to progression [ Time Frame: 2 years ]
    time to progression
  • quality of life [ Time Frame: 2 years ]
    patient reported outcome of their quality of life using FACT-BR (version 4) survey
Original Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2014)
  • overall survival [ Time Frame: 2 years ]
  • time to progression [ Time Frame: 2 years ]
  • quality of life [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketogenic Diet With Radiation and Chemotherapy for Newly Diagnosed Glioblastoma
Official Title  ICMJE 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.
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. 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma (GBM)
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Dietary Supplement: Ketogenic Diet
  • Radiation: Radiation therapy
  • Drug: Temozolomide
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 27, 2016)
14
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2014)
40
Actual Study Completion Date  ICMJE February 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02046187
Other Study ID Numbers  ICMJE KD-13BN069
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party St. Joseph's Hospital and Medical Center, Phoenix
Study Sponsor  ICMJE St. Joseph's Hospital and Medical Center, Phoenix
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Adrienne C Scheck, PhD Barrow Neurological Research
PRS Account St. Joseph's Hospital and Medical Center, Phoenix
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP