A Ketogenic Diet as a Complementary Treatment on Patients With High-grade Gliomas and Brain Metastases
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: CKD.
- Кому может быть актуально
- Состояния в реестре: Brain, Cancer. Базовые параметры: 18 лет — 80 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Греция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A "Classic" Ketogenic Diet as a Complementary Therapeutic Management on Patients With High-grade Gliomas and Brain Metastases.
Обзор
The survival interval of patients with gliomas ranges between 12 to 15 months. Recent findings revealed that dietary interventions to reduce glucose and glycolytic pathways could have a therapeutic effect. Ketosis can be an effective therapy to extend the survival of patients with gliomas.
Подробное описание
Gliomas are invasive and aggressive tumors, which derive from glial or stem cells, and after neoplastic transformation, acquire glial cell characteristics. Treatment of high-grade gliomas includes measures to relieve symptoms and eliminate or control the tumor. Surgery, radiation, and chemotherapy are the most common options. Recent findings revealed that dietary interventions to reduce glucose and glycolytic pathways could have a therapeutic effect. CKD is a restrictive therapeutic diet consisting of a 4:1 ratio of fat-to-CHO and protein. Fat provides up to 90% of the caloric intake, while overall CHO intake is less than 50 g/day. CKD reducing blood glucose levels and increasing ketone body levels stimulates biochemical changes to achieve systemic ketosis. Though, evidence for CKD in clinical practice is still limited. This study focuses on the classic ketogenic diet (CKD), adjusted for each patient's energy needs by dieticians to achieve ketosis. The primary outcome is to assess the efficacy of CKD to extend the survival of patients with high-grade gliomas and brain metastases. Historical controls will be used to compare the outcome measurements.
Вмешательства
- Другое CKD
Patients/families will meet with the study dietician to discuss the CKD, ask questions, and plan clinic visits. Training will take place about diet, meal planning, and ketones/glucose monitoring. The dietitian will follow the patient throughout treatment. Patients will measure their urine ketosis with urine test strips and capillary ketones with blood ketone meters daily, and they will complete records from the start till the end of the study. Finally, they will meet with the dietitian at follow
Первичные конечные точки
- Overall survival [Срок оценки: Participants will be followed from date of randomization until the date of death from any cause, assessed up to 36 months.]
Вторичные конечные точки (4)
- Changes in brain tumor size [Срок оценки: 2 years, Baseline, 3, 6, 12, and 24 months]
- Time to progression [Срок оценки: 2 years]
- Assessment of Quality of life using FACT-BR (version 4) survey [Срок оценки: Baseline, 3, 6, 12 months]
- Functional impairment will be assessed with the Karnofsky Performance Scale [Срок оценки: Baseline, 3, 6, 12 months]
Критерии участия
Критерии включения
- Age 18-80
- Karnofsky Performance Score of 50 or more.
- Newly diagnosed, histologically confirmed glioblastoma grade 4, or secondary metastases or progression after surgical resection, radiation and chemotherapy.
- Normal function of liver and kidneys
- Ability to sign informed consent form
Критерии исключения
- Diabetes mellitus
- Life expectancy >3 months
- Inability to adhere to diet
- Inability to give informed consent form
- Cholecystectomy last 1 year (before the study entry)
- Diagnosis of genetic disorder of fat metabolism
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
Греция · 2 центра
- Arezina Kasti — Chaïdári
- Attikon University General Hospital — Athens
Публикации
- Thomas JG, Veznedaroglu E. Ketogenic Diet for Malignant Gliomas: a Review. Curr Nutr Rep. 2020 Sep;9(3):258-263. doi: 10.1007/s13668-020-00332-2. PMID 32720120
- Sargaco B, Oliveira PA, Antunes ML, Moreira AC. Effects of the Ketogenic Diet in the Treatment of Gliomas: A Systematic Review. Nutrients. 2022 Feb 27;14(5):1007. doi: 10.3390/nu14051007. PMID 35267981
- Ebrahimpour-Koujan S, Shayanfar M, Benisi-Kohansal S, Mohammad-Shirazi M, Sharifi G, Esmaillzadeh A. Adherence to low carbohydrate diet in relation to glioma: A case-control study. Clin Nutr. 2019 Dec;38(6):2690-2695. doi: 10.1016/j.clnu.2018.11.023. Epub 2018 Nov 30. PMID 30551899
- Perry A, Wesseling P. Histologic classification of gliomas. Handb Clin Neurol. 2016;134:71-95. doi: 10.1016/B978-0-12-802997-8.00005-0. PMID 26948349
Идентификаторы
NCT: NCT05564949 · ΕΒΔ246/14-04-2022