CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
calorie-restricted ketogenic diet and transient fasting +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01754350
NCT01754350N/ACompleted

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

Johann Wolfgang Goethe University Hospital·interventional·Posted Dec 21, 2012·Updated Jun 2, 2021

In Brief

A clinical study evaluating calorie-restricted ketogenic diet and transient fasting and standard nutrition for Recurrent Glioblastoma. Completed, enrolled 50 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
CollaboratorsTavarlin

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 21, 2012
Enrollment StartMay 1, 2013
Primary CompletionDec 1, 2017
Study CompletionMar 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 13.5 years ago

Interventions

calorie-restricted ketogenic diet and transient fastingdietary

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 nutritiondietary

nutrition as recommended by the german society for nutrition, 30 kcal/kg per day