The Effect of Ketogenic Diet on Malignant Tumors- Recurrence and Progress
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01092247|
Recruitment Status : Unknown
Verified February 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was: Not yet recruiting
First Posted : March 24, 2010
Last Update Posted : March 24, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Tumors||Other: Nutritional support with Standard diet Other: Nutritional intervention with the Ketogenic diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||March 2010|
|Estimated Primary Completion Date :||May 2011|
|Estimated Study Completion Date :||September 2011|
|Placebo Comparator: Standard diet: Nutritional support||
Other: Nutritional support with Standard diet
Nutritional support with Standard diet
|Experimental: Nutritional intervention: Ketogenic 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
- 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)
- Quality of lifePerformance scale and quality of life evaluation (Karnofsky and EQ5D scale)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01092247
|Contact: Nachum Vaisman, Proffirstname.lastname@example.org|