Ketogenic Diet for Recurrent Glioblastoma (ERGO)

This study has been completed.
Sponsor:
Collaborator:
Evomed MedizinService GmbH
Information provided by (Responsible Party):
J. Rieger, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00575146
First received: December 17, 2007
Last updated: November 18, 2013
Last verified: November 2013
Results First Received: June 18, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Recurrent Glioblastoma
Intervention: Dietary Supplement: TAVARLIN

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ketogenic Diet unrestricted ketogenic diet (< 50-60 g carbohydrates per day) and dietary supplementary products provided by Tavarlin

Participant Flow:   Overall Study
    Ketogenic Diet  
STARTED     20  
COMPLETED     17  
NOT COMPLETED     3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ketogenic Diet ketogenic diet

Baseline Measures
    Ketogenic Diet  
Number of Participants  
[units: participants]
  20  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     14  
>=65 years     6  
Age  
[units: years]
Mean ± Standard Deviation
  55  ± 12.2  
Gender  
[units: participants]
 
Female     7  
Male     13  
Region of Enrollment  
[units: participants]
 
Germany     20  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Applicability as Measured by Discontinuation of Study Treatment Due to Intolerability   [ Time Frame: until progression for up to 12 months ]

2.  Secondary:   Progression-free-survival   [ Time Frame: until progression for up to 12 months ]

3.  Secondary:   Overall Survival   [ Time Frame: death/last contact, an average of about 1 year ]

4.  Secondary:   Frequency of Seizures   [ Time Frame: while on study treatment for up to 12 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Ketosis   [ Time Frame: while on study treatment for up to 12 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Quality of Life   [ Time Frame: while on study treatment for up to 12 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Ketogenic Diet ketogenic diet

Other Adverse Events
    Ketogenic Diet  
Total, other (not including serious) adverse events    
# participants affected / at risk     0/20  



  More Information
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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.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Because of the small number of patients efficacy cannot be concluded by the results of the study  


Results Point of Contact:  
Name/Title: Dr. Johannes Rieger
Organization: Dr. Senckenberg Institute of Neurooncology
phone: +49 69 6301 ext 87711
e-mail: johannes.rieger@med.uni-frankfurt.de


No publications provided


Responsible Party: J. Rieger, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT00575146     History of Changes
Other Study ID Numbers: ERGO
Study First Received: December 17, 2007
Results First Received: June 18, 2013
Last Updated: November 18, 2013
Health Authority: Germany: Ethics Commission