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Ketogenic Diet for Recurrent Glioblastoma (ERGO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00575146
Recruitment Status : Completed
First Posted : December 18, 2007
Results First Posted : December 13, 2013
Last Update Posted : May 2, 2014
Sponsor:
Collaborator:
Evomed MedizinService GmbH
Information provided by (Responsible Party):
J. Rieger, University Hospital Tuebingen

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Recurrent Glioblastoma
Intervention Dietary Supplement: TAVARLIN
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ketogenic Diet
Hide Arm/Group Description unrestricted ketogenic diet (< 50-60 g carbohydrates per day) and dietary supplementary products provided by Tavarlin
Period Title: Overall Study
Started 20
Completed 17
Not Completed 3
Arm/Group Title Ketogenic Diet
Hide Arm/Group Description ketogenic diet
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
  70.0%
>=65 years
6
  30.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
55  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
7
  35.0%
Male
13
  65.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 20 participants
20
1.Primary Outcome
Title Applicability as Measured by Discontinuation of Study Treatment Due to Intolerability
Hide Description percentage of patients who discontinued diet due to intolerability
Time Frame until progression for up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketogenic Diet
Hide Arm/Group Description:
unrestricted ketogenic diet
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: percent of participants
15
2.Secondary Outcome
Title Progression-free-survival
Hide Description measured by Macdonald-Criteria
Time Frame until progression for up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
for the analyis of PFS and OS, 3 patients who discontinued the diet in the absence of progression were excluded
Arm/Group Title Ketogenic Diet
Hide Arm/Group Description:
unrestricted ketogenic diet
Overall Number of Participants Analyzed 17
Median (Full Range)
Unit of Measure: weeks
5
(3 to 13)
3.Secondary Outcome
Title Overall Survival
Hide Description Participants were followed until reported death or last contact until 05/2011
Time Frame death/last contact, an average of about 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketogenic Diet
Hide Arm/Group Description:
unrestricted ketogenic diet
Overall Number of Participants Analyzed 20
Median (Full Range)
Unit of Measure: weeks
32
(6 to 159)
4.Secondary Outcome
Title Frequency of Seizures
Hide Description [Not Specified]
Time Frame while on study treatment for up to 12 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Ketosis
Hide Description [Not Specified]
Time Frame while on study treatment for up to 12 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Quality of Life
Hide Description [Not Specified]
Time Frame while on study treatment for up to 12 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketogenic Diet
Hide Arm/Group Description ketogenic diet
All-Cause Mortality
Ketogenic Diet
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Ketogenic Diet
Affected / at Risk (%)
Total   0/20 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ketogenic Diet
Affected / at Risk (%)
Total   0/20 (0.00%) 
Because of the small number of patients efficacy cannot be concluded by the results of the study
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Johannes Rieger
Organization: Dr. Senckenberg Institute of Neurooncology
Phone: +49 69 6301 ext 87711
EMail: johannes.rieger@med.uni-frankfurt.de
Publications of Results:
Rieger J, Bahr O, Maurer GD, Hattingen E, Franz K, Brucker D, Walenta S, Kammerer U, Coy JF, Weller M, Steinbach JP. ERGO: a pilot study of ketogenic diet in recurrent glioblastoma. Int J Oncol. 2014 Jun;44(6):1843-52. doi: 10.3892/ijo.2014.2382. Epub 2014 Apr 11. Erratum In: Int J Oncol. 2014 Dec;45(6):2605.
Layout table for additonal information
Responsible Party: J. Rieger, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT00575146    
Other Study ID Numbers: ERGO
First Submitted: December 17, 2007
First Posted: December 18, 2007
Results First Submitted: June 18, 2013
Results First Posted: December 13, 2013
Last Update Posted: May 2, 2014