cropped color_logo_with_background.png

Clinical Trial Finder

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

Study Purpose

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.

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.
  • - 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

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.

 NCT01754350
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.

 N/A
Lead Sponsor

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

 Johann Wolfgang Goethe University Hospital
Principal Investigator

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

 N/A
Principal Investigator Affiliation N/A
Agency Class

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

 Other, Industry
Overall Status Completed
Countries Germany
Conditions

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

 Recurrent Glioblastoma
Arms & Interventions

Arms

Experimental: ketogenic diet and transient fasting

Calorie-restricted, ketogenic diet and transient fasting during reirradiation

Active Comparator: standard nutrition

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

Interventions

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

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

Frankfurt, Germany

Status

Address

Dr. Senckenberg Institute of Neurooncology

Frankfurt, ,

University of Tuebingen, Tuebingen, Germany

Status

Address

University of Tuebingen

Tuebingen, ,

Powered By