NCT00575146

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2007

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

December 13, 2013

Completed
Last Updated

May 2, 2014

Status Verified

April 1, 2014

Enrollment Period

2.2 years

First QC Date

December 17, 2007

Results QC Date

June 18, 2013

Last Update Submit

April 16, 2014

Conditions

Recurrent Glioblastoma

Keywords

glioblastomaketogenic diet

Outcome Measures

Primary Outcomes (1)

  • Applicability as Measured by Discontinuation of Study Treatment Due to Intolerability

    percentage of patients who discontinued diet due to intolerability

    until progression for up to 12 months

Secondary Outcomes (5)

  • Progression-free-survival

    until progression for up to 12 months

  • Overall Survival

    death/last contact, an average of about 1 year

  • Frequency of Seizures

    while on study treatment for up to 12 months

  • Ketosis

    while on study treatment for up to 12 months

  • Quality of Life

    while on study treatment for up to 12 months

Study Arms (1)

1

EXPERIMENTAL

ketogenic diet

Dietary Supplement: TAVARLIN

Interventions

TAVARLINDIETARY_SUPPLEMENT

ketogenic diet, dietary supplementary products provided by TAVARLIN

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Senckenberg Institute of Neurooncology

Frankfurt, 60528, Germany

Location

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

Tübingen, 72076, Germany

Location

Related Publications (1)

  • 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.

    PMID: 24728273RESULT

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Limitations and Caveats

Because of the small number of patients efficacy cannot be concluded by the results of the study

Results Point of Contact

Title
Dr. Johannes Rieger
Organization
Dr. Senckenberg Institute of Neurooncology
johannes.rieger@med.uni-frankfurt.de
+49 69 6301

Study Officials

  • Johannes Rieger, MD

    Senckenberg Institute of Neurooncology, University of Frankfurt

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Johannes Rieger

Study Record Dates

First Submitted

December 17, 2007

First Posted

December 18, 2007

Study Start

December 1, 2007

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

May 2, 2014

Results First Posted

December 13, 2013

Record last verified: 2014-04

Locations

DE(2)