Health TrialsbyHealthPanel

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

ConditionsBrainCancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAttikon Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Diabetes mellitus

Life expectancy >3 months

Inability to adhere to diet

Inability to give informed consent form

Trial design

Design model

Single group

Treatments tested in this trial

  • CKD

    Other intervention

    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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Classic Ketogenic DietExperimental treatment 1 intervention

Trial outcomes

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

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

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

Time to progression

Time frame
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.

Time frame
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.

Time frame
Baseline, 3, 6, 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Attikon Hospital

Lead sponsor

Source ClinicalTrials.gov
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