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NCT Number: NCT07396896

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

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.

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Key information

Conditions

Obese Patients Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Hypothalamic Diseases Hypothalamic Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Supratentorial Neoplasms

Age range

7 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Meyer Children's Hospital IRCCS

Florence, 50139, Italy

Location status: Recruiting

Location contact

Iacopo Sardi

CONTACT

0555662631

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dietary intervention

Behavioral

Atkins Modified Diet (MAD)

Primary outcomes

  1. Percentage of patients who experience weight loss of at least 5% over 24 months

    Time frame: From enrollment to the end of the follow up period at 24 months

Secondary outcomes

  1. Percentage of patients showing weight reduction, improvement in lipid and carbohydrate parameters

    Time frame: From enrollment to the end of the follow up period at 24 months

  2. Percentage of patients with ketosis

    Time frame: From enrollement to the end of the follow up period at 24 months

  3. Percentage of patients with serious adverse events

    Time frame: From enrollement to the end of the follow up period at 24 months

  4. Adherence rate to the proposed dietary intervention, considering the number of patients who discontinue the diet and those who continue it

    Time frame: From enrollment to the end of the follow up at 24 months

  5. Percentage of patients showing reduction of lean body mass in 24 months

    Time frame: From enrollment to the end of the follow up period at 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Iacopo Sardi

CONTACT

[email protected]

0555662631

Sponsors and collaborators

Lead sponsor

Meyer Children's Hospital IRCCS

Other

Registry information

Official study title

Single-arm, Open-label, Single-center, Non-profit Interventional Clinical Trial on the Effects of the Ketogenic Diet in Patients With Brain Tumors and Central Obesity

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 9, 2026
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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