NCT07396896Recruiting
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
Source: ClinicalTrials.gov · Last updated 9 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 2 Feb 2026
- Start date
- 8 May 2025
- Primary completion date
- Apr 2028
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Diseases
- Obesity, Childhood cancers
- NCT number
- NCT07396896
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 8 May 2025 to the primary completion date, Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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).
Age in the registry: 7 years to 30 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Meyer Children's Hospital IRCCS Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.