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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 9
- 主要终点
- Overall survival
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Standard Anti-Cancer Diet
Standard Anti-Cancer Diet with Dietitian support
干预措施: Standard Anti-Cancer Diet (Behavioral)
Keto-Diet
Intensive 18-week Keto Diet intervention.
干预措施: Keto Diet (Behavioral)
结局指标
主要结局
Overall survival
时间窗: From Baseline to 18 Months
Will be calculated as the number of days from the date of patient registration to the date of death.
次要结局
- Physical activity(From Baseline to 18 Weeks)
- Cognitive performance 2(From Baseline to 18 Weeks)
- Health-related quality of life 1(From Baseline to 18 Weeks)
- Progression-free survival(From Baseline to 18 Weeks)
- Cognitive performance 1(From Baseline to 18 Weeks)
- Health-related quality of life 2(From Baseline to 18 Weeks)
研究者
Jethro Hu
Sponsor-Investigator
Cedars-Sinai Medical Center