Ketogenic Diet for Recurrent Glioblastoma

Phase 1

Completed

• Conditions: Recurrent Glioblastoma
• Interventions: Dietary Supplement: TAVARLIN

• Registration Number: NCT00575146
• Lead Sponsor: University Hospital Tuebingen

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.

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-17
• Study First Submitted QC: 2007-12-17
• Study First Posted: 2007-12-18
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Results First Submitted: 2013-06-18
• Results First Submitted QC: 2013-11-18
• Results First Posted: 2013-12-13
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-16
• Last Update Posted: 2014-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	TAVARLIN	ketogenic diet

Primary Outcome Measures

Name	Time	Method
Applicability as Measured by Discontinuation of Study Treatment Due to Intolerability	until progression for up to 12 months	percentage of patients who discontinued diet due to intolerability

Secondary Outcome Measures

Name	Time	Method
Progression-free-survival	until progression for up to 12 months	measured by Macdonald-Criteria
Overall Survival	death/last contact, an average of about 1 year	Participants were followed until reported death or last contact until 05/2011
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

Trial Locations

Locations (2)

Department of General Neurology and Hertie-Institute of Clinical Brain Research, University of Tuebingen; 🇩🇪 Tuebingen, Germany

Senckenberg Institute of Neurooncology; 🇩🇪 Frankfurt, Germany