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

NCT07396896 | Recruiting

• 1 other identifier: KETO-TUMOR
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obese Patients; Hypothalamic Neoplasms

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (5)

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

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

• Percentage of patients with ketosis

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

• Percentage of patients with serious adverse events

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

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

  From enrollment to the end of the follow up at 24 months

• Percentage of patients showing reduction of lean body mass in 24 months

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

Study Arms (1)

Keto-tumor

EXPERIMENTAL

Behavioral: Dietary intervention

Interventions

Dietary intervention BEHAVIORAL

Atkins Modified Diet (MAD)

Keto-tumor

Eligibility Criteria

• Age: 7 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Meyer Children's Hospital IRCCS: lead

Study Sites (1)

Meyer Children's Hospital IRCCS

Florence, Florence, 50139, Italy

RECRUITING

MeSH Terms

Conditions

Hypothalamic Neoplasms

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Central Study Contacts

Iacopo Sardi

CONTACT

0555662631; iacopo.sardi@meyer.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start: May 8, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)