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

Malignant Tumors Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01092247
• Other study ID #: TASMC-09-NV-0056-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: March 15, 2010
• Last updated: March 23, 2010
• Start date: March 2010
• Est. completion date: September 2011

Study information

• Verified date: February 2010
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Nachum Vaisman, Prof'
• Phone: 009-972-3-6974807
• Email: vaisman[@]tasmc.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Malignant Tumors
• Neoplasms

Intervention

Other:
• Nutritional support with Standard diet
Nutritional support with Standard diet
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center	Nutricia Liverpool

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		No
Secondary	Quality of life	Performance scale and quality of life evaluation (Karnofsky and EQ5D scale)		Yes