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Calorie-restricted, Ketogenic Diet and Transient Fasting During Reirradiation for Patients With Recurrent Glioblastoma (ERGO2)

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ClinicalTrials.gov Identifier: NCT01754350
Recruitment Status : Completed
First Posted : December 21, 2012
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
TAVARLIN (Darmstadt, Germany)
Information provided by (Responsible Party):
Johannes Rieger, Johann Wolfgang Goethe University Hospital

Tracking Information
First Submitted Date  ICMJE December 14, 2012
First Posted Date  ICMJE December 21, 2012
Last Update Posted Date April 17, 2019
Study Start Date  ICMJE May 2013
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2012)
progression-free-survival [ Time Frame: 6 months ]
Progression-free-survival rates 6 months after reirradiation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2012)
  • feasibility measured as median number on diet per patient and average calorie and carbohydrate intake per day during day 1-9 [ Time Frame: day 1-12 ]
    Feasibility of the calorie-restricted, ketogenic diet and the transient fasting measured as median number on diet per patient and average calorie and carbohydrate intake per day during day 1-9
  • Safety and Tolerability as defined as number of patients with adverse events [ Time Frame: day 1-12 ]
    Safety and tolerability of the calorie-restricted, ketogenic diet and the transient fasting as defined as number of patients with adverse events
  • progression-free-survival [ Time Frame: 1 month, 3 months ]
    progression-free-survival rates 1 month and 3 month after reirradiation
  • overall survival [ Time Frame: 12 months ]
    overall survival after the reirradiation
  • frequency of seizures [ Time Frame: day 1-12 ]
    frequency of seizures at day 1-12
  • ketosis [ Time Frame: day 1-12 ]
    urine and blood ketosis and metabolic parameters (glucose, insulin, IGF-1) during day 1-12
  • Quality of life as measured by the EORTC Quality of Life Questionnaire [ Time Frame: day 1-12 ]
    Quality of life at day 1-12 as measured by the EORTC Quality of Life Questionnaire
  • depression [ Time Frame: day 1-12 ]
    depression as measured by SCL-90 at day 1-12
  • attention [ Time Frame: day 1-12 ]
    attention as measured by d2-testing at day 1-12
  • response [ Time Frame: 1 month ]
    response assessment 1 month after reirradiation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Calorie-restricted, Ketogenic Diet and Transient Fasting During Reirradiation for Patients With Recurrent Glioblastoma
Official Title  ICMJE Calorie-restricted, Ketogenic Diet and Transient Fasting vs. Standard Nutrition During Reirradiation for Patients With Recurrent Glioblastoma: the ERGO2 Study
Brief Summary

Increased glucose metabolism is characteristic for solid tumors. Thereby, glucose is important for the generation of ATP, supply of anabolic substrates and defense against reactive oxygen species in tumor cells. In preclinical models, restricting glucose availability using a ketogenic diet, calorie-restriction or transient fasting inhibits tumor growth.

Therefore, the purpose of the study is to evaluate whether a calorie-restricted, ketogenic diet and transient fasting can enhance the efficacy of reirradiation in patients with recurrent glioblastoma.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Recurrent Glioblastoma
Intervention  ICMJE
  • Dietary Supplement: calorie-restricted ketogenic diet and transient fasting
    On day 1-3 and day 7-9, restriction of carbohydrates to < 60 g and of calories to 21-23 kcal/kg per day, on day 4-6 fasting. On day 1-3 and 7-9, restriction of carbohydrates can be supported by the use of drinks provided by "Tavarlin".
  • Dietary Supplement: standard nutrition
    nutrition as recommended by the german society for nutrition, 30 kcal/kg per day
Study Arms  ICMJE
  • Experimental: ketogenic diet and transient fasting
    Calorie-restricted, ketogenic diet and transient fasting during reirradiation
    Intervention: Dietary Supplement: calorie-restricted ketogenic diet and transient fasting
  • Active Comparator: standard nutrition
    nutrition according to recommendations of the German society for nutrition during reirradiation
    Intervention: Dietary Supplement: standard nutrition
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 Completed
Actual Enrollment  ICMJE
 (submitted: December 18, 2012)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2019
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age >= 18 years
  • recurrence of a histologically confirmed glioblastoma or gliosarcoma
  • at least 6 months after first surgery
  • at least 6 months after first radiotherapy
  • interdisciplinary recommendation for reirradiation
  • karnofsky performance status >= 60, ECOG <= 2
  • creatinine <= 2,0 mg/dl, urea <= 100 mg/dl
  • ALAT, ASAT <= 7x upper normal limit

Exclusion Criteria:

  • bowel obstruction, subileus
  • insulin-dependent diabetes
  • decompensated heart failure (NYHA > 2)
  • myocardial infarction within the last 6 months, symptomatic atrial fibrillation
  • severe acute infection
  • malnutrition, cachexia
  • other medical conditions that might increase the risk of the dietary intervention
  • pregnancy
  • uncontrolled thyroid function
  • pancreatic insufficiency
  • dementia or other clinically relevant alterations of the mental status which could impair the ability of the patient to apply to the diet or understand the informed consent of the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01754350
Other Study ID Numbers  ICMJE ERGO2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johannes Rieger, Johann Wolfgang Goethe University Hospital
Study Sponsor  ICMJE Johann Wolfgang Goethe University Hospital
Collaborators  ICMJE TAVARLIN (Darmstadt, Germany)
Investigators  ICMJE Not Provided
PRS Account Johann Wolfgang Goethe University Hospital
Verification Date April 2019

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