Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID05564949

A Classic Ketogenic Diet as Complementary Treatment for Patients With High-grade Gliomas and Brain Metastases

Led by Attikon Hospital · Updated on 2025-05-31

15

Participants Needed

2

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Gliomas are aggressive tumors that originate from glial or stem cells, with patients typically surviving between 12 to 15 months. This research investigates whether a classic ketogenic diet (CKD), which restricts carbohydrate intake and increases fat consumption to induce ketosis, can help extend survival in patients with high-grade gliomas and brain metastases. The study compares outcomes to historical controls to evaluate the diet's potential therapeutic effect. Participants will follow the CKD for an initial period of 3 months, which is a high-fat, low-carbohydrate diet adjusted to each patient's energy needs by dietitians. This diet aims to reduce blood glucose levels and increase ketone bodies to stimulate biochemical changes. Patients and their families will receive training on meal planning and ketone/glucose monitoring, and dietitians will provide ongoing support and follow-up visits. Throughout the study, participants will regularly monitor their urine and blood ketone levels daily and maintain records. Researchers will assess overall survival up to 36 months, tumor size changes, time to progression, quality of life, and functional impairment using established scales and surveys. Follow-up evaluations will occur at baseline and various intervals up to 24 months. The study includes safety assessments and continues monitoring until death or the study endpoint.

CONDITIONS

Brief Title

A Ketogenic Diet as a Complementary Treatment on Patients With High-grade Gliomas and Brain Metastases

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 80 years
  • Karnofsky Performance Score of 50 or more
  • Newly diagnosed, histologically confirmed glioblastoma grade 4, or secondary metastases or progression after surgical resection, radiation, and chemotherapy
  • Normal liver and kidney function
  • Ability to sign informed consent form
Not Eligible

You will not qualify if you...

  • Diabetes mellitus
  • Life expectancy greater than 3 months
  • Inability to adhere to diet
  • Inability to give informed consent form
  • Gallbladder removal within the last year
  • Diagnosis of genetic disorder of fat metabolism

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 3 months with possible extension depending on diet compliance

Participants follow a classic ketogenic diet (CKD) tailored by dieticians to achieve ketosis, with daily monitoring of urine and blood ketones and regular dietitian follow-up.

Regular visits with dietitian and daily self-monitoring of ketones

Follow-up

Duration - Up to 36 months

Participants are followed for up to 36 months to assess overall survival and monitor tumor progression and quality of life.

Visits at baseline, 3, 6, 12, 24 months for assessments

Trial Site Locations

Total: 2 locations

1

Arezina Kasti

Chaïdári, Athens, Greece, 12461

Actively Recruiting

2

Attikon University General Hospital

Athens, Greece, 12462

Actively Recruiting

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Research Team

A

Arezina N. Kasti, RD

E

Evangelos K. Papadopoulos, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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