Ketogenic Diet for Recurrent Glioblastoma

Recurrent Glioblastoma Clinical Trial

— ERGO  

Official title:

Ketogenic Diet for Patients With Recurrent Glioblastoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00575146
• Other study ID #: ERGO
• Status: Completed
• Phase: Phase 1
• First received: December 17, 2007
• Last updated: April 16, 2014
• Start date: December 2007
• Est. completion date: February 2010

Study information

• Verified date: April 2014
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioblastoma
• Recurrent Glioblastoma

Intervention

Dietary Supplement:
• TAVARLIN
ketogenic diet, dietary supplementary products provided by TAVARLIN

Locations

Country	Name	City	State
Germany	Senckenberg Institute of Neurooncology	Frankfurt
Germany	Department of General Neurology and Hertie-Institute of Clinical Brain Research, University of Tuebingen	Tuebingen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Evomed MedizinService GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Rieger J, Bähr O, Maurer GD, Hattingen E, Franz K, Brucker D, Walenta S, Kämmerer 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 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Progression-free-survival	measured by Macdonald-Criteria	until progression for up to 12 months	No
Secondary	Overall Survival	Participants were followed until reported death or last contact until 05/2011	death/last contact, an average of about 1 year	No
Secondary	Frequency of Seizures		while on study treatment for up to 12 months	No
Secondary	Ketosis		while on study treatment for up to 12 months	No
Secondary	Quality of Life		while on study treatment for up to 12 months	No