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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01092247

Enrollment

Registered

2010-03-24

Start date

2010-03-31

Completion date

2011-09-30

Last updated

2010-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Tumors

Keywords

Patients with malignant tumors

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.

Interventions

OTHERNutritional support with Standard diet

Nutritional support with Standard diet

OTHERNutritional 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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Quality of life	—	Performance scale and quality of life evaluation (Karnofsky and EQ5D scale)

Contacts

Primary ContactNachum Vaisman, Prof'

vaisman@tasmc.health.gov.il009-972-3-6974807

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026