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

NCT01754350 | Completed Results

• 1 other identifier: ERGO2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

ketogenic diet; glioma; fasting; reirradiation; nutrition

Outcome Measures

Primary Outcomes (1)

• Progression-free-survival

  Progression-free-survival rates 6 months after reirradiation based on response assessment in neuro-oncology criteria (RANO)

  6 months

Secondary Outcomes (10)

• Feasibility 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

• Safety and Tolerability as Defined as Number of Patients With Adverse Events

  day 1-12

• Progression-free-survival

  1 month, 3 months

• Overall Survival

  12 months

• Frequency of Seizures

  day 1-12

Study Arms (2)

ketogenic diet and transient fasting

EXPERIMENTAL

Calorie-restricted, ketogenic diet and transient fasting during reirradiation

Dietary Supplement: calorie-restricted ketogenic diet and transient fasting

standard nutrition

ACTIVE COMPARATOR

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

Dietary Supplement: standard nutrition

Interventions

calorie-restricted ketogenic diet and transient fasting DIETARY_SUPPLEMENT

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".

ketogenic diet and transient fasting

standard nutrition DIETARY_SUPPLEMENT

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

standard nutrition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johann Wolfgang Goethe University Hospital: lead
• Tavarlin: collaborator

Study Sites (2)

Dr. Senckenberg Institute of Neurooncology

Frankfurt, Germany

Location

University of Tuebingen

Tübingen, Germany

Location

Related Publications (3)

• Voss M, Wenger KJ, von Mettenheim N, Bojunga J, Vetter M, Diehl B, Franz K, Gerlach R, Ronellenfitsch MW, Harter PN, Hattingen E, Steinbach JP, Rodel C, Rieger J. Short-term fasting in glioma patients: analysis of diet diaries and metabolic parameters of the ERGO2 trial. Eur J Nutr. 2022 Feb;61(1):477-487. doi: 10.1007/s00394-021-02666-1. Epub 2021 Sep 6.

  PMID: 34487222 DERIVED

• Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.

  PMID: 33512717 DERIVED

• Voss M, Wagner M, von Mettenheim N, Harter PN, Wenger KJ, Franz K, Bojunga J, Vetter M, Gerlach R, Glatzel M, Paulsen F, Hattingen E, Baehr O, Ronellenfitsch MW, Fokas E, Imhoff D, Steinbach JP, Rodel C, Rieger J. ERGO2: A Prospective, Randomized Trial of Calorie-Restricted Ketogenic Diet and Fasting in Addition to Reirradiation for Malignant Glioma. Int J Radiat Oncol Biol Phys. 2020 Nov 15;108(4):987-995. doi: 10.1016/j.ijrobp.2020.06.021. Epub 2020 Jun 30.

  PMID: 32619561 DERIVED

MeSH Terms

Conditions

Glioblastoma; Glioma; Fasting

Condition Hierarchy (Ancestors)

Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Feeding Behavior; Behavior

Results Point of Contact

• Title: Johannes Rieger
• Organization: JohannWGUH

j.rieger@uni-tuebingen.de

+4969630187711

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: December 14, 2012
• First Posted: December 21, 2012
• Study Start: May 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: March 1, 2019
• Last Updated: June 2, 2021
• Results First Posted: June 2, 2021

Record last verified: 2021-05

Locations

DE (2)