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临床试验/NCT05564949
NCT05564949招募中不适用

A "Classic" Ketogenic Diet as a Complementary Therapeutic Management on Patients With High-grade Gliomas and Brain Metastases.

Attikon Hospital4 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2022年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
15
试验地点
4
主要终点
Overall survival

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Overall survival

时间窗: Participants will be followed from date of randomization until the date of death from any cause, assessed up to 36 months.

次要结局

  • Functional impairment will be assessed with the Karnofsky Performance Scale(Baseline, 3, 6, 12 months)
  • Changes in brain tumor size(2 years, Baseline, 3, 6, 12, and 24 months)
  • Time to progression(2 years)
  • Assessment of Quality of life using FACT-BR (version 4) survey(Baseline, 3, 6, 12 months)

研究者

发起方
Attikon Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Arezina Kasti

Registered Dietitian, MSc, PhDc

Attikon Hospital

研究点 (4)

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