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NCT Number: NCT00575146

Ketogenic Diet for Recurrent Glioblastoma

To determine whether a mild ketogenic diet can influences quality of life and survival of patients with recurrent glioblastoma

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Key information

Conditions

Recurrent Glioblastoma Astrocytoma 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

Phase 1

Primary location

Senckenberg Institute of Neurooncology, Frankfurt, Germany

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About this study

Increased glycolysis and reduced oxidative phosphorylation is a characteristic property of many tumors. A change of nutrition by limiting carbohydrates and increasing the proportion of fatty acids and proteins can lead to ketogenic metabolism and might limit energy production in tumor cells and therefore inhibit tumor growth. Standard treatment for glioblastoma includes resection, irradiation and temozolomide chemotherapy. If there is tumor recurrence, no standard therapy is established. Therapeutic options in this situation include resection, irradiation or another chemotherapy. However, some patients cannot be treated in this situation, because none of the available treatment options seems reasonable or applicable, for example if no additional chemotherapy can be started at the time of recurrence due to myelosuppression. The pilot study examines whether in this situation a ketogenic diet can be applied to the patients and may inhibit tumor growth and influence the quality of life of the patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age >= 18 years
  • histological diagnosis of glioblastoma or gliosarcoma
  • on MRI measurable tumor
  • interval of at least 6 months after primary resection
  • completed radiotherapy, interval of at least 3 months after completion of radiotherapy
  • relapse during or after temozolomide chemotherapy, other chemotherapy not possible, not reasonable or not wanted by the patient
  • Karnofsky-Index >= 60%, ECOG <= 2
  • life expectancy of at least 12 weeks
  • creatinine <= 1.5 mg/dl, urea <= 50 mg/dl
  • INR <= 1,5, GOT <= 7 x of normal value, GPT <= 7 x of normal value

Exclusion criteria

  • bowel obstruction or subileus
  • diabetes mellitus, HbA1c > 6,1 %
  • heart failure (NYHA > 2), myocardial infarction within the last 6 months, atrial fibrillation
  • acute infection
  • conditions that may strongly reduce compliance to the diet or increase risk of the diet
  • dementia or clinically relevant alterations of the mental state which interfere with the applicability of the diet

Treatment and study plan

TAVARLIN

Dietary Supplement

ketogenic diet, dietary supplementary products provided by TAVARLIN

Primary outcomes

  1. Applicability as Measured by Discontinuation of Study Treatment Due to Intolerability

    Time frame: until progression for up to 12 months

    percentage of patients who discontinued diet due to intolerability

Secondary outcomes

  1. Progression-free-survival

    Time frame: until progression for up to 12 months

    measured by Macdonald-Criteria

  2. Overall Survival

    Time frame: death/last contact, an average of about 1 year

    Participants were followed until reported death or last contact until 05/2011

  3. Frequency of Seizures

    Time frame: while on study treatment for up to 12 months

  4. Ketosis

    Time frame: while on study treatment for up to 12 months

  5. Quality of Life

    Time frame: while on study treatment for up to 12 months

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • Evomed MedizinService GmbH

Registry information

Official study title

Ketogenic Diet for Patients With Recurrent Glioblastoma

Acronym: ERGO

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Dec 18, 2007
Registry last updated
May 2, 2014

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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