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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
Results First Posted : June 2, 2021
Last Update Posted : June 2, 2021
Sponsor:
Collaborator:
TAVARLIN (Darmstadt, Germany)
Information provided by (Responsible Party):
Johannes Rieger, Johann Wolfgang Goethe University Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Recurrent Glioblastoma Dietary Supplement: calorie-restricted ketogenic diet and transient fasting Dietary Supplement: standard nutrition Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Calorie-restricted, Ketogenic Diet and Transient Fasting vs. Standard Nutrition During Reirradiation for Patients With Recurrent Glioblastoma: the ERGO2 Study
Study Start Date : May 2013
Actual Primary Completion Date : December 2017
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ketogenic diet and transient fasting
Calorie-restricted, ketogenic diet and transient fasting during reirradiation
 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".
Active Comparator: standard nutrition
nutrition according to recommendations of the German society for nutrition during reirradiation
 Dietary Supplement: standard nutrition
nutrition as recommended by the german society for nutrition, 30 kcal/kg per day


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free-survival [ Time Frame: 6 months ]
    Progression-free-survival rates 6 months after reirradiation based on response assessment in neuro-oncology criteria (RANO)


Secondary Outcome Measures :
  1. Feasibility Measured as Median Number of Days 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 of days on diet per patient and average calorie and carbohydrate intake per day during day 1-9

  2. 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

  3. Progression-free-survival [ Time Frame: 1 month, 3 months ]
    progression-free-survival rates 1 month and 3 month after reirradiation

  4. Overall Survival [ Time Frame: 12 months ]
    overall survival after the reirradiation

  5. Frequency of Seizures [ Time Frame: day 1-12 ]
    frequency of seizures at day 1-12

  6. Ketosis [ Time Frame: day 1-12 ]
    urine and blood ketosis and metabolic parameters (glucose, insulin, IGF-1) during day 1-12

  7. 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

  8. Depression [ Time Frame: day 1-12 ]
    depression as measured by SCL-90 at day 1-12

  9. Attention [ Time Frame: day 1-12 ]
    attention as measured by d2-testing at day 1-12

  10. Response [ Time Frame: 1 month ]
    response assessment 1 month after reirradiation


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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01754350


Locations
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Germany
Dr. Senckenberg Institute of Neurooncology
Frankfurt, Germany
University of Tuebingen
Tuebingen, Germany
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
TAVARLIN (Darmstadt, Germany)
  Study Documents (Full-Text)

Documents provided by Johannes Rieger, Johann Wolfgang Goethe University Hospital:
Study Protocol and Statistical Analysis Plan  [PDF] August 21, 2016

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Johannes Rieger, PD Dr. med., Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT01754350    
Other Study ID Numbers: ERGO2
First Posted: December 21, 2012    Key Record Dates
Results First Posted: June 2, 2021
Last Update Posted: June 2, 2021
Last Verified: May 2021
Keywords provided by Johannes Rieger, Johann Wolfgang Goethe University Hospital:
ketogenic diet
glioma
fasting
reirradiation
nutrition
Additional relevant MeSH terms:
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Glioblastoma
Recurrence
Disease Attributes
Pathologic Processes
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
 Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue