The Effect of Ketogenic Diet on Malignant Tumors- Recurrence and Progress
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
The aim of the study is, to study the efficacy of the ketogenic diet in delaying or preventing recurrence and tumor growth progression of patients who have been previously treated by concomitant chemoradiotherapy (6 months) for high-grade glial tumors. It will be an open-label trial of nutritional intervention for up to 1 year. An interim analysis of the data will be carried out to assess safety, compliance and efficacy of the diet. This will be reviewed by both SHS and the Clinical trial team.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2010
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 15, 2010
CompletedFirst Posted
Study publicly available on registry
March 24, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedMarch 24, 2010
February 1, 2010
1.2 years
March 15, 2010
March 23, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To study the effect of the ketogenic diet on tumor growth progression and longevity in patients with Malignant glioblastoma.
This will be done by comparing tumor size by repeated MRI studies (every 2 months)
Secondary Outcomes (1)
Quality of life
Study Arms (2)
Standard diet: Nutritional support
PLACEBO COMPARATORNutritional intervention: Ketogenic diet.
EXPERIMENTALInterventions
Nutritional support with Standard diet
Nutritional intervention with ketogenic diet. The Diet plan will be based on each patient individually according to his nutritional needs. Age, weight, activity levels, culture and food preferences are taken in consideration
Eligibility Criteria
You may qualify if:
- Consenting adults aged ≥ 18 years.
- Recurrent or progressive high grade glioma after failure of at least one line of standard oncological treatment.
- Gliomatosis cerebri, including patients declining radiation treatment.
You may not qualify if:
- Patients with malignant tumors who are receiving treatment at the time of the recruitment.
- Early termination - patients who will wish to stop their participation in the trial will discontinue the ketogenic diet and return to their usual diet.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tel-Aviv Sourasky Medical Centerlead
- Nutricia Liverpoolcollaborator
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
March 15, 2010
First Posted
March 24, 2010
Study Start
March 1, 2010
Primary Completion
May 1, 2011
Study Completion
September 1, 2011
Last Updated
March 24, 2010
Record last verified: 2010-02