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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Nutricia Liverpool
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01092247
First received: March 15, 2010
Last updated: March 23, 2010
Last verified: February 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label

Resource links provided by NLM:

U.S. FDA Resources

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. [ Designated as safety issue: No ]
    This will be done by comparing tumor size by repeated MRI studies (every 2 months)


Secondary Outcome Measures:
  • Quality of life [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 15, 2010
Last Updated: March 23, 2010
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 22, 2013