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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое Dietary intervention
  Atkins Modified Diet (MAD)

Первичные конечные точки

• Percentage of patients who experience weight loss of at least 5% over 24 months [Срок оценки: From enrollment to the end of the follow up period at 24 months]

Вторичные конечные точки (5)

• Percentage of patients showing weight reduction, improvement in lipid and carbohydrate parameters [Срок оценки: From enrollment to the end of the follow up period at 24 months]
• Percentage of patients with ketosis [Срок оценки: From enrollement to the end of the follow up period at 24 months]
• Percentage of patients with serious adverse events [Срок оценки: 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 [Срок оценки: From enrollment to the end of the follow up at 24 months]
• Percentage of patients showing reduction of lean body mass in 24 months [Срок оценки: From enrollment to the end of the follow up period at 24 months]

Критерии участия

Критерии включения

• 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).

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Meyer Children's Hospital IRCCS — Florence

Идентификаторы

NCT: NCT07396896 · KETO-TUMOR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗