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The Effect of Ketogenic Diet on Malignant Tumors- Recurrence and Progress

Study Purpose

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.

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 - 85 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion criteria:

1. Consenting adults aged ≥ 18 years. 2. Recurrent or progressive high grade glioma after failure of at least one line of standard oncological treatment. 3. Gliomatosis cerebri, including patients declining radiation treatment.

Exclusion criteria:

1. Patients with malignant tumors who are receiving treatment at the time of the recruitment. 2. Early termination

- patients who will wish to stop their participation in the trial will discontinue the ketogenic diet and return to their usual 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.	NCT01092247
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.	Tel-Aviv Sourasky Medical Center
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	Unknown status
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Malignant Tumors

Arms & Interventions

Arms

Placebo Comparator: Standard diet: Nutritional support

Experimental: Nutritional intervention: Ketogenic diet.

Interventions

Other: - Nutritional support with Standard diet

Nutritional support with Standard diet

Other: - Nutritional intervention with the Ketogenic 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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Nachum Vaisman, Prof'

[email protected]

009-972-3-6974807

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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