Histologic classification of gliomas.
Arie Perry, Pieter Wesseling
https://pubmed.ncbi.nlm.nih.gov/26948349/Actively Recruiting
Led by Attikon Hospital · Updated on 2025-05-31
15
Participants Needed
2
Research Sites
17 weeks
Total Duration
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 diets 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 patients 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 ketoneglucose 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
A Ketogenic Diet as a Complementary Treatment on Patients With High-grade Gliomas and Brain Metastases
A
Arezina N. Kasti, RD
E
Evangelos K. Papadopoulos, MD
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Attikon Hospital
Lead Sponsor
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Arie Perry, Pieter Wesseling
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https://pubmed.ncbi.nlm.nih.gov/30551899/Attikon Hospital
Lead Sponsor