Calorie-restricted, Ketogenic Diet and Transient Fasting During Reirradiation for Patients With Recurrent Glioblastoma (ERGO2)

Johann Wolfgang Goethe University Hospital

Status: Completed

Conditions: Recurrent Glioblastoma

Treatments: Dietary Supplement: standard nutrition; Dietary Supplement: calorie-restricted ketogenic diet and transient fasting

Study type: Interventional

Funder types: Other

Identifiers

NCT01754350

ERGO2

Details and patient eligibility

About

Increased glucose metabolism is characteristic for solid tumors. Thereby, glucose is important for the generation of ATP, supply of anabolic substrates and defense against reactive oxygen species in tumor cells. In preclinical models, restricting glucose availability using a ketogenic diet, calorie-restriction or transient fasting inhibits tumor growth.

Therefore, the purpose of the study is to evaluate whether a calorie-restricted, ketogenic diet and transient fasting can enhance the efficacy of reirradiation in patients with recurrent glioblastoma.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age >= 18 years
• recurrence of a histologically confirmed glioblastoma or gliosarcoma
• at least 6 months after first surgery
• at least 6 months after first radiotherapy
• interdisciplinary recommendation for reirradiation
• karnofsky performance status >= 60, ECOG <= 2
• creatinine <= 2,0 mg/dl, urea <= 100 mg/dl
• ALAT, ASAT <= 7x upper normal limit

Exclusion criteria

• bowel obstruction, subileus
• insulin-dependent diabetes
• decompensated heart failure (NYHA > 2)
• myocardial infarction within the last 6 months, symptomatic atrial fibrillation
• severe acute infection
• malnutrition, cachexia
• other medical conditions that might increase the risk of the dietary intervention
• pregnancy
• uncontrolled thyroid function
• pancreatic insufficiency
• dementia or other clinically relevant alterations of the mental status which could impair the ability of the patient to apply to the diet or understand the informed consent of the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

ketogenic diet and transient fasting

Experimental group

Description:

Calorie-restricted, ketogenic diet and transient fasting during reirradiation

Treatment:

Dietary Supplement: calorie-restricted ketogenic diet and transient fasting

standard nutrition

Active Comparator group

Description:

nutrition according to recommendations of the German society for nutrition during reirradiation

Treatment:

Dietary Supplement: standard nutrition