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Completed

NCT Number: NCT01754350

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

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.

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Key information

Conditions

Recurrent Glioblastoma Astrocytoma Behavior Fasting Feeding Behavior Glioblastoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Senckenberg Institute of Neurooncology, Frankfurt, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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".

standard nutrition

Dietary Supplement

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

Primary outcomes

  1. Progression-free-survival

    Time frame: 6 months

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

Secondary outcomes

  1. Feasibility Measured as Median Number of Days on Diet Per Patient and Average Calorie and Carbohydrate Intake Per Day During Day 1-9

    Time frame: day 1-12

    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

  2. Safety and Tolerability as Defined as Number of Patients With Adverse Events

    Time frame: day 1-12

    Safety and tolerability of the calorie-restricted, ketogenic diet and the transient fasting as defined as number of patients with adverse events

  3. Progression-free-survival

    Time frame: 1 month, 3 months

    progression-free-survival rates 1 month and 3 month after reirradiation

  4. Overall Survival

    Time frame: 12 months

    overall survival after the reirradiation

  5. Frequency of Seizures

    Time frame: day 1-12

    frequency of seizures at day 1-12

  6. Ketosis

    Time frame: day 1-12

    urine and blood ketosis and metabolic parameters (glucose, insulin, IGF-1) during day 1-12

  7. Quality of Life as Measured by the EORTC Quality of Life Questionnaire

    Time frame: day 1-12

    Quality of life at day 1-12 as measured by the EORTC Quality of Life Questionnaire

  8. Depression

    Time frame: day 1-12

    depression as measured by SCL-90 at day 1-12

  9. Attention

    Time frame: day 1-12

    attention as measured by d2-testing at day 1-12

  10. Response

    Time frame: 1 month

    response assessment 1 month after reirradiation

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Collaborators

  • Tavarlin

Registry information

Official study title

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

Acronym: ERGO2

Important dates

Study start
2013
Primary completion
2017
Study completion
2019
First posted
Dec 21, 2012
Registry last updated
Jun 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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