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

Recurrent Glioblastoma Clinical Trial

— ERGO2  

Official title:

Calorie-restricted, Ketogenic Diet and Transient Fasting vs. Standard Nutrition During Reirradiation for Patients With Recurrent Glioblastoma: the ERGO2 Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01754350
• Other study ID #: ERGO2
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: March 2019

Study information

• Verified date: May 2021
• Source: Johann Wolfgang Goethe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Recurrent Glioblastoma

Intervention

Dietary Supplement:
• calorie-restricted ketogenic diet and transient fasting
On day 1-3 and day 7-9, restriction of carbohydrates to < 60 g and of calories to 21-23 kcal/kg per day, on day 4-6 fasting. On day 1-3 and 7-9, restriction of carbohydrates can be supported by the use of drinks provided by "Tavarlin".
• standard nutrition
nutrition as recommended by the german society for nutrition, 30 kcal/kg per day

Locations

Country	Name	City	State
Germany	Dr. Senckenberg Institute of Neurooncology	Frankfurt
Germany	University of Tuebingen	Tuebingen

Sponsors (2)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital	TAVARLIN (Darmstadt, Germany)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free-survival	Progression-free-survival rates 6 months after reirradiation based on response assessment in neuro-oncology criteria (RANO)	6 months
Secondary	Feasibility Measured as Median Number of Days on Diet Per Patient and Average Calorie and Carbohydrate Intake Per Day During Day 1-9	Feasibility of the calorie-restricted, ketogenic diet and the transient fasting measured as median number of days on diet per patient and average calorie and carbohydrate intake per day during day 1-9	day 1-12
Secondary	Safety and Tolerability as Defined as Number of Patients With Adverse Events	Safety and tolerability of the calorie-restricted, ketogenic diet and the transient fasting as defined as number of patients with adverse events	day 1-12
Secondary	Progression-free-survival	progression-free-survival rates 1 month and 3 month after reirradiation	1 month, 3 months
Secondary	Overall Survival	overall survival after the reirradiation	12 months
Secondary	Frequency of Seizures	frequency of seizures at day 1-12	day 1-12
Secondary	Ketosis	urine and blood ketosis and metabolic parameters (glucose, insulin, IGF-1) during day 1-12	day 1-12
Secondary	Quality of Life as Measured by the EORTC Quality of Life Questionnaire	Quality of life at day 1-12 as measured by the EORTC Quality of Life Questionnaire	day 1-12
Secondary	Depression	depression as measured by SCL-90 at day 1-12	day 1-12
Secondary	Attention	attention as measured by d2-testing at day 1-12	day 1-12
Secondary	Response	response assessment 1 month after reirradiation	1 month