Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07396896

Recruiting nowNot applicableInterventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age7 Years to 30 Years

SexAll

Healthy volunteersNot accepted

ConditionObese Patients, Hypothalamic Neoplasms

Full registry criteria

Inclusion Criteria: 1. Diagnosis of hypothalamic-chiasmatic tumour according to the WHO 2021 classification 2. Diagnosis of hypothalamic obesity: after 5 years of age, BMI \>97th percentile in the WHO 2007 curves 3. Males and females aged between 7 and 30 years 4. Performance status: Lansky score \> 40 for patients aged \< 18 years and Karnofsky score \> 40 for patients aged between 18 and 30 years 5. Signature of informed consent to participate in the study 6. Signature of consent by the minor patient to participate in the study (7-13 years and 14-17 years). Exclusion Criteria: 1\. 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.

Treatments and study arms

Dietary intervention

Behavioral

Atkins Modified Diet (MAD)

Primary outcomes

Percentage of patients who experience weight loss of at least 5% over 24 monthsFrom enrollment to the end of the follow up period at 24 months

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Meyer Children's Hospital IRCCS🇮🇹 Florence, Florence, Italy

Open map

Iacopo SardiContact

Call 0555662631