Back to results

Ketogenic Diet for Recurrent Glioblastoma (ERGO)

Primary Purpose

Recurrent Glioblastoma

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

TAVARLIN

About this trial

This is an interventional treatment trial for Recurrent Glioblastoma focused on measuring glioblastoma, ketogenic diet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Senckenberg Institute of Neurooncology
Department of General Neurology and Hertie-Institute of Clinical Brain Research, University of Tuebingen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

ketogenic diet

Outcomes

Primary Outcome Measures

Applicability as Measured by Discontinuation of Study Treatment Due to Intolerability

percentage of patients who discontinued diet due to intolerability

Secondary Outcome Measures

Progression-free-survival

measured by Macdonald-Criteria

Overall Survival

Participants were followed until reported death or last contact until 05/2011

Frequency of Seizures

Ketosis

Quality of Life

Full Information

NCT ID

NCT00575146

First Posted

December 17, 2007

Last Updated

April 16, 2014

Sponsor

University Hospital Tuebingen

Collaborators

Evomed MedizinService GmbH

1. Study Identification

Unique Protocol Identification Number

NCT00575146

Brief Title

Ketogenic Diet for Recurrent Glioblastoma

Acronym

ERGO

Official Title

Ketogenic Diet for Patients With Recurrent Glioblastoma

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

December 2007 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital Tuebingen

Collaborators

Evomed MedizinService GmbH

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Glioblastoma

Keywords

glioblastoma, ketogenic diet

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

ketogenic diet

Intervention Type

Dietary Supplement

Intervention Name(s)

TAVARLIN

Intervention Description

ketogenic diet, dietary supplementary products provided by TAVARLIN

Primary Outcome Measure Information:

Title

Applicability as Measured by Discontinuation of Study Treatment Due to Intolerability

Description

percentage of patients who discontinued diet due to intolerability

Time Frame

until progression for up to 12 months

Secondary Outcome Measure Information:

Title

Progression-free-survival

Description

measured by Macdonald-Criteria

Time Frame

until progression for up to 12 months

Title

Overall Survival

Description

Participants were followed until reported death or last contact until 05/2011

Time Frame

death/last contact, an average of about 1 year

Title

Frequency of Seizures

Time Frame

while on study treatment for up to 12 months

Title

Ketosis

Time Frame

while on study treatment for up to 12 months

Title

Quality of Life

Time Frame

while on study treatment for up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Johannes Rieger, MD

Organizational Affiliation

Senckenberg Institute of Neurooncology, University of Frankfurt

Official's Role

Principal Investigator

Facility Information:

Facility Name

Senckenberg Institute of Neurooncology

City

Frankfurt

ZIP/Postal Code

60528

Country

Germany

Facility Name

Department of General Neurology and Hertie-Institute of Clinical Brain Research, University of Tuebingen

City

Tuebingen

ZIP/Postal Code

72076

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

24728273

Citation

Rieger J, Bahr O, Maurer GD, Hattingen E, Franz K, Brucker D, Walenta S, Kammerer 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.

Results Reference

result

Learn more about this trial

Ketogenic Diet for Recurrent Glioblastoma

We'll reach out to this number within 24 hrs