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

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.

• 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

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.