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

Primary Purpose

Recurrent Glioblastoma

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
calorie-restricted ketogenic diet and transient fasting
standard nutrition
Sponsored by
Johann Wolfgang Goethe University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Glioblastoma focused on measuring ketogenic diet, glioma, fasting, reirradiation, nutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dr. Senckenberg Institute of Neurooncology
  • University of Tuebingen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ketogenic diet and transient fasting

standard nutrition

Arm Description

Calorie-restricted, ketogenic diet and transient fasting during reirradiation

nutrition according to recommendations of the German society for nutrition during reirradiation

Outcomes

Primary Outcome Measures

Progression-free-survival
Progression-free-survival rates 6 months after reirradiation based on response assessment in neuro-oncology criteria (RANO)

Secondary Outcome Measures

Feasibility Measured as Median Number of Days on Diet Per Patient and Average Calorie and Carbohydrate Intake Per Day During Day 1-9
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
Safety and Tolerability as Defined as Number of Patients With Adverse Events
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
progression-free-survival rates 1 month and 3 month after reirradiation
Overall Survival
overall survival after the reirradiation
Frequency of Seizures
frequency of seizures at day 1-12
Ketosis
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
Quality of life at day 1-12 as measured by the EORTC Quality of Life Questionnaire
Depression
depression as measured by SCL-90 at day 1-12
Attention
attention as measured by d2-testing at day 1-12
Response
response assessment 1 month after reirradiation

Full Information

First Posted
December 14, 2012
Last Updated
May 30, 2021
Sponsor
Johann Wolfgang Goethe University Hospital
Collaborators
TAVARLIN (Darmstadt, Germany)
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1. Study Identification

Unique Protocol Identification Number
NCT01754350
Brief Title
Calorie-restricted, Ketogenic Diet and Transient Fasting During Reirradiation for Patients With Recurrent Glioblastoma
Acronym
ERGO2
Official Title
Calorie-restricted, Ketogenic Diet and Transient Fasting vs. Standard Nutrition During Reirradiation for Patients With Recurrent Glioblastoma: the ERGO2 Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johann Wolfgang Goethe University Hospital
Collaborators
TAVARLIN (Darmstadt, Germany)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Glioblastoma
Keywords
ketogenic diet, glioma, fasting, reirradiation, nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ketogenic diet and transient fasting
Arm Type
Experimental
Arm Description
Calorie-restricted, ketogenic diet and transient fasting during reirradiation
Arm Title
standard nutrition
Arm Type
Active Comparator
Arm Description
nutrition according to recommendations of the German society for nutrition during reirradiation
Intervention Type
Dietary Supplement
Intervention Name(s)
calorie-restricted ketogenic diet and transient fasting
Intervention Description
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".
Intervention Type
Dietary Supplement
Intervention Name(s)
standard nutrition
Intervention Description
nutrition as recommended by the german society for nutrition, 30 kcal/kg per day
Primary Outcome Measure Information:
Title
Progression-free-survival
Description
Progression-free-survival rates 6 months after reirradiation based on response assessment in neuro-oncology criteria (RANO)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Feasibility Measured as Median Number of Days on Diet Per Patient and Average Calorie and Carbohydrate Intake Per Day During Day 1-9
Description
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
Time Frame
day 1-12
Title
Safety and Tolerability as Defined as Number of Patients With Adverse Events
Description
Safety and tolerability of the calorie-restricted, ketogenic diet and the transient fasting as defined as number of patients with adverse events
Time Frame
day 1-12
Title
Progression-free-survival
Description
progression-free-survival rates 1 month and 3 month after reirradiation
Time Frame
1 month, 3 months
Title
Overall Survival
Description
overall survival after the reirradiation
Time Frame
12 months
Title
Frequency of Seizures
Description
frequency of seizures at day 1-12
Time Frame
day 1-12
Title
Ketosis
Description
urine and blood ketosis and metabolic parameters (glucose, insulin, IGF-1) during day 1-12
Time Frame
day 1-12
Title
Quality of Life as Measured by the EORTC Quality of Life Questionnaire
Description
Quality of life at day 1-12 as measured by the EORTC Quality of Life Questionnaire
Time Frame
day 1-12
Title
Depression
Description
depression as measured by SCL-90 at day 1-12
Time Frame
day 1-12
Title
Attention
Description
attention as measured by d2-testing at day 1-12
Time Frame
day 1-12
Title
Response
Description
response assessment 1 month after reirradiation
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Dr. Senckenberg Institute of Neurooncology
City
Frankfurt
Country
Germany
Facility Name
University of Tuebingen
City
Tuebingen
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
34487222
Citation
Voss M, Wenger KJ, von Mettenheim N, Bojunga J, Vetter M, Diehl B, Franz K, Gerlach R, Ronellenfitsch MW, Harter PN, Hattingen E, Steinbach JP, Rodel C, Rieger J. Short-term fasting in glioma patients: analysis of diet diaries and metabolic parameters of the ERGO2 trial. Eur J Nutr. 2022 Feb;61(1):477-487. doi: 10.1007/s00394-021-02666-1. Epub 2021 Sep 6.
Results Reference
derived
PubMed Identifier
33512717
Citation
Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
Results Reference
derived
PubMed Identifier
32619561
Citation
Voss M, Wagner M, von Mettenheim N, Harter PN, Wenger KJ, Franz K, Bojunga J, Vetter M, Gerlach R, Glatzel M, Paulsen F, Hattingen E, Baehr O, Ronellenfitsch MW, Fokas E, Imhoff D, Steinbach JP, Rodel C, Rieger J. ERGO2: A Prospective, Randomized Trial of Calorie-Restricted Ketogenic Diet and Fasting in Addition to Reirradiation for Malignant Glioma. Int J Radiat Oncol Biol Phys. 2020 Nov 15;108(4):987-995. doi: 10.1016/j.ijrobp.2020.06.021. Epub 2020 Jun 30.
Results Reference
derived

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

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