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Ketogenic Diet for Recurrent Glioblastoma

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00575146
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University Hospital Tuebingen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Johannes Rieger, MD
Principal Investigator Affiliation Senckenberg Institute of Neurooncology, University of Frankfurt
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Recurrent Glioblastoma
Additional Details

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.

Arms & Interventions

Arms

Experimental: 1

ketogenic diet

Interventions

Dietary Supplement: - TAVARLIN

ketogenic diet, dietary supplementary products provided by TAVARLIN

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Senckenberg Institute of Neurooncology, Frankfurt, Germany

Status

Address

Senckenberg Institute of Neurooncology

Frankfurt, , 60528

Tuebingen, Germany

Status

Address

Department of General Neurology and Hertie-Institute of Clinical Brain Research, University of Tuebingen

Tuebingen, , 72076

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