Actively Recruiting
KETO-TUMOR: a Study on Brain Tumors and Central Obesity
Led by Meyer Children's Hospital IRCCS · Updated on 2026-02-09
30
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Hypothalamic-chiasmatic tumours account for 5-10% of CNS tumours in children and can compromise hypothalamic function, causing alterations in energy balance and weight gain. In inoperable cases, chemotherapy and radiotherapy are used; the latter, although the gold standard, is associated with significant neurocognitive and endocrine-metabolic side effects, proportional to the hypothalamic damage. The ketogenic diet, used for decades in the treatment of drug-resistant childhood epilepsy, induces the use of ketone bodies as a source of energy for the brain and is effective in controlling seizures. Among the different variants, the modified Atkins diet was chosen in this study to promote better patient adherence. This study aims to evaluate the effectiveness of the ketogenic diet (KD) in treating central obesity secondary to hypothalamic-chiasmatic tumours (gliomas, craniopharyngiomas, germ cell tumours, etc.), which often lead to excessive weight gain. This is refractory to drug therapy and lifestyle changes, such as low-calorie diets and exercise.
CONDITIONS
Official Title
KETO-TUMOR: a Study on Brain Tumors and Central Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of hypothalamic-chiasmatic tumour according to the WHO 2021 classification
- Diagnosis of hypothalamic obesity with BMI above the 97th percentile after 5 years of age
- Males and females aged between 7 and 30 years
- Performance status: Lansky score above 40 if under 18 years; Karnofsky score above 40 if 18 to 30 years old
- Signed informed consent to participate
- Signed consent from minor patients aged 7 to 17 years
You will not qualify if you...
- Deficiencies of primary carnitine
- Deficiencies of carnitine palmitoyltransferase 2 (CPT 2)
- Deficiencies of carnitine acylcarnitine translocase (CACT)
- Deficiencies of beta-oxidation
- Deficiencies of medium-chain acyl-CoA dehydrogenase (MCAD)
- Deficiencies of long-chain acyl-CoA dehydrogenase (LCAD)
- Deficiencies of short-chain acyl-CoA dehydrogenase (SCAD)
- Porphyria
- Pyruvate carboxylase deficiency
- Deficiencies of long-chain 3-hydroxyacyl-CoA dehydrogenase
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Meyer Children's Hospital IRCCS
Florence, Florence, Italy, 50139
Actively Recruiting
Research Team
I
Iacopo Sardi
CONTACT
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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