Menu
Recruiting NCT07396896

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

No phase Interventional Obese Patients Hypothalamic Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dietary intervention.
Who it may be relevant to
Registry conditions: Obese Patients, Hypothalamic Neoplasms. Basic parameters: 7 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Behavioral Dietary intervention
    Atkins Modified Diet (MAD)

Primary outcome measures

  • 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 outcome measures (5)
  • 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]
  • Percentage of patients with ketosis [Time frame: From enrollement to the end of the follow up period at 24 months]
  • Percentage of patients with serious adverse events [Time frame: 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 [Time frame: From enrollment to the end of the follow up at 24 months]
  • 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]

Eligibility criteria

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Meyer Children's Hospital IRCCS — Florence

Identifiers

NCT: NCT07396896 · KETO-TUMOR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗