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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01092247
First Posted: March 24, 2010
Last Update Posted: March 24, 2010
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.
Collaborator:
Nutricia Liverpool
Information provided by:
Tel-Aviv Sourasky Medical Center
  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.


Condition Intervention
Malignant Tumors Other: Nutritional support with Standard diet Other: Nutritional intervention with the Ketogenic diet

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

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


Estimated Enrollment: 40
Study Start Date: March 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01092247


Contacts
Contact: Nachum Vaisman, Prof' 009-972-3-6974807 vaisman@tasmc.health.gov.il

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Nutricia Liverpool
  More Information

Responsible Party: Faith Takurukura BAppSc. PGDip.Diet. RGN, Clinical Trials Specialist, Research & Development, Nutricia Liverpool
ClinicalTrials.gov Identifier: NCT01092247     History of Changes
Other Study ID Numbers: TASMC-09-NV-0056-CTIL
First Submitted: March 15, 2010
First Posted: March 24, 2010
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:
Neoplasms