Health TrialsbyHealthPanel

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

ConditionsObese PatientsHypothalamic Neoplasms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-30
SponsorMeyer Children's Hospital IRCCS

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Primary carnitine

Carnitine palmitoyltransferase 2 (CPT 2)

Carnitine acylcarnitine translocase (CACT)

Beta-oxidation

Trial design

Design model

Single group

Treatments tested in this trial

  • Dietary intervention

    Behavioral

    Atkins Modified Diet (MAD)

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Keto-tumorExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Meyer Children's Hospital IRCCS

Lead sponsor

Source ClinicalTrials.gov
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