RecruitingNot ApplicableNCT07396896

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

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


Sponsor

Meyer Children's Hospital IRCCS

Enrollment

30 participants

Start Date

May 8, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 7 YearsMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a ketogenic (very low-carb, high-fat) diet can help manage weight and metabolic problems in children and young adults with hypothalamic obesity — a type of severe, hard-to-treat weight gain caused by brain tumors near the hypothalamus, the part of the brain that controls hunger and metabolism. **You may be eligible if...** - You are between 7 and 30 years old - You have been diagnosed with a hypothalamic or chiasmatic brain tumor (a tumor near the brain's appetite-control center) - You have hypothalamic obesity (BMI above the 97th percentile after age 5) - You are able to carry out basic daily activities **You may NOT be eligible if...** - You have uncontrolled diabetes or serious metabolic conditions that would make a ketogenic diet dangerous - You have recently started a new medication that affects weight or metabolism - You have active or unstable tumor progression requiring urgent treatment - You have conditions making a high-fat diet medically unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALDietary intervention

Atkins Modified Diet (MAD)


Locations(1)

Meyer Children's Hospital IRCCS

Florence, Florence, Italy

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NCT07396896


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