NCT01754350

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Johann Wolfgang Goethe University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Glioblastoma

Interventions

Type	Name	Description
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".
DIETARY_SUPPLEMENT	standard nutrition	nutrition as recommended by the german society for nutrition, 30 kcal/kg per day

Timeline

• Start date: 2013-05-01
• Primary completion: 2017-12-01
• Completion: 2019-03-01
• First posted: 2012-12-21
• Last updated: 2021-06-02
• Results posted: 2021-06-02

Locations

2 sites across 1 country: Germany