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. 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
Nutricia Liverpool
Information provided by:
Tel-Aviv Sourasky Medical Center

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.

Condition or disease Intervention/treatment
Malignant Tumors Other: Nutritional support with Standard diet Other: Nutritional intervention with the Ketogenic diet

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  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 Outcome Measures :
  1. Quality of life
    Performance scale and quality of life evaluation (Karnofsky and EQ5D scale)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01092247

Contact: Nachum Vaisman, Prof' 009-972-3-6974807

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Nutricia Liverpool

Responsible Party: Faith Takurukura BAppSc. PGDip.Diet. RGN, Clinical Trials Specialist, Research & Development, Nutricia Liverpool Identifier: NCT01092247     History of Changes
Other Study ID Numbers: TASMC-09-NV-0056-CTIL
First Posted: March 24, 2010    Key Record Dates
Last Update Posted: March 24, 2010
Last Verified: February 2010

Keywords provided by Tel-Aviv Sourasky Medical Center:
Patients with malignant tumors

Additional relevant MeSH terms: