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NCT Number: NCT05564949

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

The survival interval of patients with gliomas ranges between 12 to 15 months. Recent findings revealed that dietary interventions to reduce glucose and glycolytic pathways could have a therapeutic effect. Ketosis can be an effective therapy to extend the survival of patients with gliomas.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arezina Kasti, Chaïdári, Athens, Greece

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About this study

Gliomas are invasive and aggressive tumors, which derive from glial or stem cells, and after neoplastic transformation, acquire glial cell characteristics. Treatment of high-grade gliomas includes measures to relieve symptoms and eliminate or control the tumor. Surgery, radiation, and chemotherapy are the most common options. Recent findings revealed that dietary interventions to reduce glucose and glycolytic pathways could have a therapeutic effect. CKD is a restrictive therapeutic diet consisting of a 4:1 ratio of fat-to-CHO and protein. Fat provides up to 90% of the caloric intake, while overall CHO intake is less than 50 g/day. CKD reducing blood glucose levels and increasing ketone body levels stimulates biochemical changes to achieve systemic ketosis. Though, evidence for CKD in clinical practice is still limited. This study focuses on the classic ketogenic diet (CKD), adjusted for each patient's energy needs by dieticians to achieve ketosis. The primary outcome is to assess the efficacy of CKD to extend the survival of patients with high-grade gliomas and brain metastases. Historical controls will be used to compare the outcome measurements.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-80
  • 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 function of liver and kidneys
  • Ability to sign informed consent form

Exclusion criteria

  • Diabetes mellitus
  • Life expectancy >3 months
  • Inability to adhere to diet
  • Inability to give informed consent form
  • Cholecystectomy last 1 year (before the study entry)
  • Diagnosis of genetic disorder of fat metabolism

Treatment and study plan

CKD

Other

Patients/families will meet with the study dietician to discuss the CKD, ask questions, and plan clinic visits. Training will take place about diet, meal planning, and ketones/glucose monitoring. The dietitian will follow the patient throughout treatment. Patients will measure their urine ketosis with urine test strips and capillary ketones with blood ketone meters daily, and they will complete records from the start till the end of the study. Finally, they will meet with the dietitian at follow-up visits and on an as-needed basis.

Primary outcomes

  1. Overall survival

    Time frame: Participants will be followed from date of randomization until the date of death from any cause, assessed up to 36 months.

Secondary outcomes

  1. Changes in brain tumor size

    Time frame: 2 years, Baseline, 3, 6, 12, and 24 months

    MRI (Magnetic Resonance Imaging) will be used to measure changes in tumor size (cm^2)

  2. Time to progression

    Time frame: 2 years

  3. Assessment of Quality of life using FACT-BR (version 4) survey

    Time frame: Baseline, 3, 6, 12 months

    50-item FACT-Br (Functional Assessment of Cancer Therapy - Brain) is a self-report and interview when applicable questionnaire used to assess quality of life, which includes domains such as Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, Brain Cancer Subscale. Each of them is rated based on the Likert scale from 1 to 5.

  4. Functional impairment will be assessed with the Karnofsky Performance Scale

    Time frame: Baseline, 3, 6, 12 months

    The scoring is assigned by a health professional based on the hierarchical scale: 100=normal, no evidence of disease, while 10=death. Intermediate or decimal scores can be assigned.

Study contacts

Contact information is provided by the study sponsor or research team.

Arezina N. Kasti, RD

CONTACT

[email protected]

+306942917860 ext. +30

Evangelos K. Papadopoulos, MD

CONTACT

[email protected]

6936251274 ext. +30

Sponsors and collaborators

Lead sponsor

Attikon Hospital

Other

Registry information

Official study title

A "Classic" Ketogenic Diet as a Complementary Therapeutic Management on Patients With High-grade Gliomas and Brain Metastases.

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Oct 4, 2022
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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