Actively Recruiting

Phase Not Applicable
Age: 7Years - 30Years
All Genders
NCT07396896

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

Age: 7Years - 30Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Meyer Children's Hospital IRCCS

Florence, Florence, Italy, 50139

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here