A Phase 2 Study of the Ketogenic Diet vs Standard Anti-cancer Diet Guidance for Patients With Glioblastoma in Combination With Standard-of-care Treatment

Официальное название

A Randomized Controlled Phase 2 Study of the Ketogenic Diet Versus Standard Dietary Guidance for Patients With Newly Diagnosed Glioblastoma in Combination With Standard-of-care Treatment

Обзор

This is a Phase 2, randomized two-armed, multi-site study of 170 patients with newly diagnosed glioblastoma multiforme. Patients will be randomized 1:1 to receive Keto Diet, or Standard Anti-Cancer Diet. All patients will receive standard of care treatment for their glioblastoma. The Keto Diet intervention will be for an 18-week period and conducted by trained research dietitians. Daily ketone and glucose levels will be recorded to monitor Keto Diet adherence. This two-armed randomized multi-site study aims to provide evidence to support the hypothesis that a Keto Diet vs. Standard Anti-Cancer Diet improves overall survival in newly diagnosed glioblastoma multiforme patients who receive standard of care treatment.

Вмешательства

• Поведенческое Keto Diet
  The experimental intervention includes a strict and controlled diet that manages daily macronutrient breakdown and increases the ratio of dietary fat relative to protein and carbohydrate consumption.
• Поведенческое Standard Anti-Cancer Diet
  Dietitian sessions will utilize the American Institute for Cancer Research Food resources and will reference foods low in fats such as fruits, vegetables and whole grains, providing key micronutrients and phytonutrients. Sessions will also focus on dietary support to help decrease any treatment related symptoms.

Первичные конечные точки

• Overall survival [Срок оценки: From Baseline to 18 Months]

Вторичные конечные точки (7)

• Health-related quality of life 1 [Срок оценки: From Baseline to 18 Weeks]
• Health-related quality of life 2 [Срок оценки: From Baseline to 18 Weeks]
• Progression-free survival [Срок оценки: From Baseline to 18 Weeks]
• Cognitive performance 1 [Срок оценки: From Baseline to 18 Weeks]
• Cognitive performance 2 [Срок оценки: From Baseline to 18 Weeks]
• Physical activity [Срок оценки: From Baseline to 18 Weeks]
• Physical activity [Срок оценки: From Baseline to 18 Weeks]

Критерии участия

Критерии включения

• Adults 18 years or older
• Newly diagnosed glioblastoma (Within 2 months of initial diagnosis by histopathology)
• Not started standard of care chemotherapy and/or radiation therapy for glioblastoma
• Karnofsky Performance Status (KPS) ≥ 70
• Ability to read, write and understand either English OR Spanish
• Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Критерии исключения

• Patients with recurrent glioblastoma
• Genetic disorders that affect lipid metabolism. Including but not limited to pyruvate carboxylase deficiency, porphyria, primary carnitine deficiency, carnitine palmitoyltransferase I or II deficiency, carnitine translocase deficiency, beta-oxidation defects
• Inability to wean steroids below 8mg dexamethasone / day or equivalent
• Body Mass Index (BMI) < 21kg/m2, unless the site Principal Investigator deems safe
• Currently pregnant or nursing
• Patients receiving other experimental therapy Note: Off-label therapy use is permitted
• Comorbidities that in the opinion of the investigator limit the patient's ability to complete the study
• Food preferences incompatible with keto diet
• Using a pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implants (removable hearing aids permitted), or other electronic medical equipment, unless the site Principal Investigator deems safe
• Inability to participant in standard of care MRIs

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 5 центров

• Cedars-Sinai Medical Center — Los Angeles
• University of California, San Francisco — San Francisco
• Pacific Neuroscience Institute / Saint John's Cancer Institute — Santa Monica
• Duke University — Durham
• Medical College of Wisconsin — Milwaukee

Идентификаторы

NCT: NCT05708352 · IIT2022-06-HU-DIET2TREAT · R01CA276919

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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