Ketogenic Diet for Recurrent Glioblastoma (ERGO)

April 16, 2014 updated by: J. Rieger, University Hospital Tuebingen

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt, Germany, 60528
        • Senckenberg Institute of Neurooncology
      • Tuebingen, Germany, 72076
        • Department of General Neurology and Hertie-Institute of Clinical Brain Research, University of Tuebingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
ketogenic diet
Dietary supplement: TAVARLIN
ketogenic diet, dietary supplementary products provided by TAVARLIN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
until progression for up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free-survival
Time Frame: until progression for up to 12 months
measured by Macdonald-Criteria
until progression for up to 12 months
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
death/last contact, an average of about 1 year
Frequency of Seizures
Time Frame: while on study treatment for up to 12 months
while on study treatment for up to 12 months
Ketosis
Time Frame: while on study treatment for up to 12 months
while on study treatment for up to 12 months
Quality of Life
Time Frame: while on study treatment for up to 12 months
while on study treatment for up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Collaborators

Evomed MedizinService GmbH

Investigators

  • Principal Investigator: Johannes Rieger, MD, Senckenberg Institute of Neurooncology, University of Frankfurt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (ACTUAL)

February 1, 2010

Study Completion (ACTUAL)

February 1, 2010

Study Registration Dates

First Submitted

December 17, 2007

First Submitted That Met QC Criteria

December 17, 2007

First Posted (ESTIMATE)

December 18, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

May 2, 2014

Last Update Submitted That Met QC Criteria

April 16, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERGO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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