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Ketogenic Diet for Recurrent Glioblastoma (ERGO)

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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

Tracking Information
First Submitted Date  ICMJE December 17, 2007
First Posted Date  ICMJE December 18, 2007
Results First Submitted Date  ICMJE June 18, 2013
Results First Posted Date  ICMJE December 13, 2013
Last Update Posted Date May 2, 2014
Study Start Date  ICMJE December 2007
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2013)
Applicability as Measured by Discontinuation of Study Treatment Due to Intolerability [ Time Frame: until progression for up to 12 months ]
percentage of patients who discontinued diet due to intolerability
Original Primary Outcome Measures  ICMJE
 (submitted: December 17, 2007)
applicability [ Time Frame: until progression ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2013)
  • Progression-free-survival [ Time Frame: until progression for up to 12 months ]
    measured by Macdonald-Criteria
  • Overall Survival [ Time Frame: death/last contact, an average of about 1 year ]
    Participants were followed until reported death or last contact until 05/2011
  • Frequency of Seizures [ Time Frame: while on study treatment for up to 12 months ]
  • Ketosis [ Time Frame: while on study treatment for up to 12 months ]
  • Quality of Life [ Time Frame: while on study treatment for up to 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2007)
applicability PFS after 6 weeks, 3 months and 6 months after treatment started survival after treatment started overall survival frequency of epileptic seizures ketogenic state quality of life [ Time Frame: until progression ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketogenic Diet for Recurrent Glioblastoma
Official Title  ICMJE Ketogenic Diet for Patients With Recurrent Glioblastoma
Brief Summary To determine whether a mild ketogenic diet can influences quality of life and survival of patients with recurrent glioblastoma
Detailed Description Increased glycolysis and reduced oxidative phosphorylation is a characteristic property of many tumors. A change of nutrition by limiting carbohydrates and increasing the proportion of fatty acids and proteins can lead to ketogenic metabolism and might limit energy production in tumor cells and therefore inhibit tumor growth. Standard treatment for glioblastoma includes resection, irradiation and temozolomide chemotherapy. If there is tumor recurrence, no standard therapy is established. Therapeutic options in this situation include resection, irradiation or another chemotherapy. However, some patients cannot be treated in this situation, because none of the available treatment options seems reasonable or applicable, for example if no additional chemotherapy can be started at the time of recurrence due to myelosuppression. The pilot study examines whether in this situation a ketogenic diet can be applied to the patients and may inhibit tumor growth and influence the quality of life of the patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Recurrent Glioblastoma
Intervention  ICMJE Dietary Supplement: TAVARLIN
ketogenic diet, dietary supplementary products provided by TAVARLIN
Study Arms  ICMJE Experimental: 1
ketogenic diet
Intervention: Dietary Supplement: TAVARLIN
Publications * Rieger J, Bähr O, Maurer GD, Hattingen E, Franz K, Brucker D, Walenta S, Kämmerer 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 17, 2007)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age >= 18 years
  • histological diagnosis of glioblastoma or gliosarcoma
  • on MRI measurable tumor
  • interval of at least 6 months after primary resection
  • completed radiotherapy, interval of at least 3 months after completion of radiotherapy
  • relapse during or after temozolomide chemotherapy, other chemotherapy not possible, not reasonable or not wanted by the patient
  • Karnofsky-Index >= 60%, ECOG <= 2
  • life expectancy of at least 12 weeks
  • creatinine <= 1.5 mg/dl, urea <= 50 mg/dl
  • INR <= 1,5, GOT <= 7 x of normal value, GPT <= 7 x of normal value

Exclusion Criteria:

  • bowel obstruction or subileus
  • diabetes mellitus, HbA1c > 6,1 %
  • heart failure (NYHA > 2), myocardial infarction within the last 6 months, atrial fibrillation
  • acute infection
  • conditions that may strongly reduce compliance to the diet or increase risk of the diet
  • dementia or clinically relevant alterations of the mental state which interfere with the applicability of the diet
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00575146
Other Study ID Numbers  ICMJE ERGO
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party J. Rieger, University Hospital Tuebingen
Study Sponsor  ICMJE University Hospital Tuebingen
Collaborators  ICMJE Evomed MedizinService GmbH
Investigators  ICMJE
Principal Investigator: Johannes Rieger, MD Senckenberg Institute of Neurooncology, University of Frankfurt
PRS Account University Hospital Tuebingen
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP