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

Not Applicable

• Conditions: Malignant Tumors
• Interventions: Other: Nutritional support with Standard diet; Other: Nutritional intervention with the Ketogenic diet

• Registration Number: NCT01092247
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-02
• Study Start: 2010-03
• Study First Submitted: 2010-03-15
• Study First Submitted QC: 2010-03-23
• Last Update Submitted: 2010-03-23
• Study First Posted: 2010-03-24
• Last Update Posted: 2010-03-24
• Primary Completion: 2011-05
• Study Completion: 2011-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard diet: Nutritional support	Nutritional support with Standard diet	-
Nutritional intervention: Ketogenic diet.	Nutritional intervention with the Ketogenic diet	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Quality of life		Performance scale and quality of life evaluation (Karnofsky and EQ5D scale)