Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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:
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

March 15, 2010
March 23, 2010
March 2010
May 2011   (final data collection date for primary outcome measure)
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)
Same as current
No Changes Posted
Quality of life [ Designated as safety issue: Yes ]
Performance scale and quality of life evaluation (Karnofsky and EQ5D scale)
Same as current
Not Provided
Not Provided
 
The Effect of Ketogenic Diet on Malignant Tumors- Recurrence and Progress
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Malignant Tumors
  • 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
  • Placebo Comparator: Standard diet: Nutritional support
    Intervention: Other: Nutritional support with Standard diet
  • Experimental: Nutritional intervention: Ketogenic diet.
    Intervention: Other: Nutritional intervention with the Ketogenic diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
40
September 2011
May 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01092247
TASMC-09-NV-0056-CTIL
Not Provided
Not Provided
Not Provided
Faith Takurukura BAppSc. PGDip.Diet. RGN, Clinical Trials Specialist, Research & Development, Nutricia Liverpool
Tel-Aviv Sourasky Medical Center
Nutricia Liverpool
Not Provided
Tel-Aviv Sourasky Medical Center
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP