KETO-TUMOR: a Study on Brain Tumors and Central Obesity

Recruiting · NCT07396896 · Interventional (participants receive a specific treatment) · Lead sponsor: Meyer Children's Hospital IRCCS

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Obesity

Interventions studied

Dietary intervention

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.

Who can take part

Age range

7 Years to 30 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

Diagnosis of hypothalamic-chiasmatic tumour according to the WHO 2021 classification
Diagnosis of hypothalamic obesity: after 5 years of age, BMI \>97th percentile in the WHO 2007 curves
Males and females aged between 7 and 30 years
Performance status: Lansky score \> 40 for patients aged \< 18 years and Karnofsky score \> 40 for patients aged between 18 and 30 years
Signature of informed consent to participate in the study
Signature of consent by the minor patient to participate in the study (7-13 years and 14-17 years).

Exclusion criteria

\. Deficiencies of:
Primary carnitine
Carnitine palmitoyltransferase 2 (CPT 2)
Carnitine acylcarnitine translocase (CACT)
Beta-oxidation
Medium-chain acyl-CoA dehydrogenase (MCAD)
long-chain acyl-CoA dehydrogenase (LCAD)
short-chain acyl-CoA dehydrogenase (SCAD)
porphyria
pyruvate carboxylase
long-chain 3-hydroxyacyl-CoA dehydrogenase.

Where it is running

1 location listed.

Meyer Children's Hospital IRCCS - Florence, Florence, Italy

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →