Ketogenic Diet for Recurrent Glioblastoma (ERGO)

University Hospital Tuebingen

Status and phase: Completed; Phase 1

Conditions: Recurrent Glioblastoma

Treatments: Dietary Supplement: TAVARLIN

Study type: Interventional

Funder types: Other

Identifiers

NCT00575146

ERGO

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

1

Experimental group

Description:

ketogenic diet

Treatment:

Dietary Supplement: TAVARLIN