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BrainNCT05564949

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

A study testing CKD in people with Brain and Cancer, run by Attikon Hospital at 2 sites in Greece.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Brain, Cancer
What is being tested?
CKD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
2 sitesGreece
Study dates
20 Sep 2022to 28 Feb 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Arezina N. Kasti, RD contact

+306942917860 ext. +30

kastiare@yahoo.gr

Evangelos K. Papadopoulos, MD contact

6936251274 ext. +30

neuroevan@yahoo.gr

Greece2 sites, 2 recruiting

  • Attikon University General Hospital

    Athens, 12462

    Arezina N. Kasti, RD, 2105832575 ext. +30, kastiare@yahoo.gr

    Evangelos K. Papadopoulos, MD, 6936251274 ext. +30, neuroevan@yahoo.gr

    Recruiting

  • Arezina Kasti

    Chaïdári, Athens, 12461

    Arezina N. Kasti, RD, +306942917860 ext. +30, kastiare@yahoo.gr

    Evangelos K. Papadopoulos, MD, 6936251274 ext. +30, neuroevan@yahoo.gr

    Recruiting

Other trials in Greece

About this study

Official title: A "Classic" Ketogenic Diet as a Complementary Therapeutic Management 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.

Read the detailed description

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.

Conditions
Brain, Cancer
Being tested
CKD
Keywords
ketogenic, diet, gliomas, metastases
Medical subject headings
Neoplasms, Glioma, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CKDOther

    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.

Study groups in NCT05564949
Study groupRoleWhat they receive
Classic Ketogenic DietExperimentalPatients will adhere to a classic ketogenic diet for a period of 3 months with a possible extension depending on their compliance on the diet.
Receives: Other: CKD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

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

Secondary outcomes (4)

  1. Changes in brain tumor size

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

    Measured: 2 years, Baseline, 3, 6, 12, and 24 months

  2. Time to progression

    Measured: 2 years

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

    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.

    Measured: Baseline, 3, 6, 12 months

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

    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.

    Measured: Baseline, 3, 6, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2022
  2. Study start20 Sep 2022
  3. Primary completion30 Oct 2025 (estimated)
  4. Study completion28 Feb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Patients will adhere to a classic ketogenic diet for a period of 3 months with a possible extension depending on their compliance on the diet.
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05564949
Sponsor's protocol ID
ΕΒΔ246/14-04-2022
Status last verified
May 2025
First submitted
22 Sep 2022
Last updated
31 May 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Thomas JG, Veznedaroglu E. Ketogenic Diet for Malignant Gliomas: a Review. Curr Nutr Rep. 2020 Sep;9(3):258-263. doi: 10.1007/s13668-020-00332-2.

    PubMed 32720120

  • Sargaco B, Oliveira PA, Antunes ML, Moreira AC. Effects of the Ketogenic Diet in the Treatment of Gliomas: A Systematic Review. Nutrients. 2022 Feb 27;14(5):1007. doi: 10.3390/nu14051007.

    PubMed 35267981

  • Ebrahimpour-Koujan S, Shayanfar M, Benisi-Kohansal S, Mohammad-Shirazi M, Sharifi G, Esmaillzadeh A. Adherence to low carbohydrate diet in relation to glioma: A case-control study. Clin Nutr. 2019 Dec;38(6):2690-2695. doi: 10.1016/j.clnu.2018.11.023. Epub 2018 Nov 30.

    PubMed 30551899

  • Perry A, Wesseling P. Histologic classification of gliomas. Handb Clin Neurol. 2016;134:71-95. doi: 10.1016/B978-0-12-802997-8.00005-0.

    PubMed 26948349

Questions about this trial

What is this clinical trial studying?

A study testing CKD in people with Brain and Cancer, run by Attikon Hospital at 2 sites in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Arezina N. Kasti, RD (+306942917860 ext. +30, kastiare@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05564949, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.

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