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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
Evomed MedizinService GmbH
Information provided by (Responsible Party):
J. Rieger, University Hospital Tuebingen

Brief Summary:
To determine whether a mild ketogenic diet can influences quality of life and survival of patients with recurrent glioblastoma

Condition or disease Intervention/treatment Phase
Recurrent Glioblastoma Dietary Supplement: TAVARLIN Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ketogenic Diet for Patients With Recurrent Glioblastoma
Study Start Date : December 2007
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
ketogenic diet
Dietary Supplement: TAVARLIN
ketogenic diet, dietary supplementary products provided by TAVARLIN

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Progression-free-survival [ Time Frame: until progression for up to 12 months ]
    measured by Macdonald-Criteria

  2. 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

  3. Frequency of Seizures [ Time Frame: while on study treatment for up to 12 months ]
  4. Ketosis [ Time Frame: while on study treatment for up to 12 months ]
  5. Quality of Life [ Time Frame: while on study treatment for up to 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00575146

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Senckenberg Institute of Neurooncology
Frankfurt, Germany, 60528
Department of General Neurology and Hertie-Institute of Clinical Brain Research, University of Tuebingen
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Evomed MedizinService GmbH
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Principal Investigator: Johannes Rieger, MD Senckenberg Institute of Neurooncology, University of Frankfurt
Publications of Results:
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Responsible Party: J. Rieger, Dr. Johannes Rieger, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT00575146    
Other Study ID Numbers: ERGO
First Posted: December 18, 2007    Key Record Dates
Results First Posted: December 13, 2013
Last Update Posted: May 2, 2014
Last Verified: April 2014
Keywords provided by J. Rieger, University Hospital Tuebingen:
ketogenic diet
Additional relevant MeSH terms:
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Disease Attributes
Pathologic Processes
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue