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

This study is currently recruiting participants.
Verified May 2013 by Johann Wolfgang Goethe University Hospitals
Sponsor:
Collaborator:
TAVARLIN (Darmstadt, Germany)
Information provided by (Responsible Party):
Johannes Rieger, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01754350
First received: December 14, 2012
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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 Intervention
Recurrent Glioblastoma
Dietary Supplement: calorie-restricted ketogenic diet and transient fasting
Dietary Supplement: standard nutrition

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • progression-free-survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Progression-free-survival rates 6 months after reirradiation


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    progression-free-survival rates 1 month and 3 month after reirradiation

  • overall survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    overall survival after the reirradiation

  • frequency of seizures [ Time Frame: day 1-12 ] [ Designated as safety issue: No ]
    frequency of seizures at day 1-12

  • ketosis [ Time Frame: day 1-12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Quality of life at day 1-12 as measured by the EORTC Quality of Life Questionnaire

  • depression [ Time Frame: day 1-12 ] [ Designated as safety issue: No ]
    depression as measured by SCL-90 at day 1-12

  • attention [ Time Frame: day 1-12 ] [ Designated as safety issue: No ]
    attention as measured by d2-testing at day 1-12

  • response [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    response assessment 1 month after reirradiation


Estimated Enrollment: 50
Study Start Date: May 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01754350

Contacts
Contact: Johannes Rieger, Dr. +49 69 6301 ext 87711 johannes.rieger@med.uni-frankfurt.de
Contact: Joachim P Steinbach, Prof. +49 69 6301 ext 87711 joachim.steinbach@med.uni-frankfurt.de

Locations
Germany
Dr. Senckenberg Institute of Neurooncology Recruiting
Frankfurt, Germany
Contact: Johannes Rieger, MD    +49696301 ext 87711    johannes.rieger@med.uni-frankfurt.de   
Contact: Joachim Steinbach, MD    +49696301 ext 87711    joachim.steinbach@med.uni-frankfurt.de   
Principal Investigator: Johannes Rieger, MD         
Principal Investigator: Joachim Steinbach, MD         
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
TAVARLIN (Darmstadt, Germany)
  More Information

No publications provided

Responsible Party: Johannes Rieger, PD Dr. med., Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01754350     History of Changes
Other Study ID Numbers: ERGO2
Study First Received: December 14, 2012
Last Updated: May 29, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Johann Wolfgang Goethe University Hospitals:
ketogenic diet
glioma
fasting
reirradiation
nutrition

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on April 22, 2014