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

December 17, 2007
November 18, 2013
December 2007
February 2010   (final data collection date for primary outcome measure)
Applicability as Measured by Discontinuation of Study Treatment Due to Intolerability [ Time Frame: until progression for up to 12 months ] [ Designated as safety issue: Yes ]
percentage of patients who discontinued diet due to intolerability
applicability [ Time Frame: until progression ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00575146 on ClinicalTrials.gov Archive Site
  • Progression-free-survival [ Time Frame: until progression for up to 12 months ] [ Designated as safety issue: No ]
    measured by Macdonald-Criteria
  • Overall Survival [ Time Frame: death/last contact, an average of about 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Ketosis [ Time Frame: while on study treatment for up to 12 months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: while on study treatment for up to 12 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Ketogenic Diet for Recurrent Glioblastoma
Ketogenic Diet for Patients With Recurrent Glioblastoma

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

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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Recurrent Glioblastoma
Dietary Supplement: TAVARLIN
ketogenic diet, dietary supplementary products provided by TAVARLIN
Experimental: 1
ketogenic diet
Intervention: Dietary Supplement: TAVARLIN
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
February 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00575146
ERGO
No
J. Rieger, University Hospital Tuebingen
University Hospital Tuebingen
Evomed MedizinService GmbH
Principal Investigator: Johannes Rieger, MD Senckenberg Institute of Neurooncology, University of Frankfurt
University Hospital Tuebingen
November 2013

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