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

Tel Aviv Sourasky Medical Center

Status: Unknown

Conditions: Malignant Tumors

Treatments: Other: Nutritional intervention with the Ketogenic diet; Other: Nutritional support with Standard diet

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01092247

TASMC-09-NV-0056-CTIL

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

40 participants in 2 patient groups, including a placebo group

Standard diet: Nutritional support

Placebo Comparator group

Treatment:

Other: Nutritional support with Standard diet

Nutritional intervention: Ketogenic diet.

Experimental group

Treatment:

Other: Nutritional intervention with the Ketogenic diet