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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:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Recurrent Glioblastoma
Intervention: Dietary Supplement: TAVARLIN

  Participant Flow


  Baseline Characteristics

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 
Overall Participants Analyzed 
[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

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 reported.   Anticipated Reporting Date:   No text entered.  

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

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


  Serious Adverse Events


  Other Adverse Events


  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


  More Information