Blood-based Bioenergetic Profiling and Cognition in Glioblastoma Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of Patients Completing Bioenergetics Profiling
研究概览
简要总结
This trial studies the use of blood-based bioenergetic profiling and cognitive testing in assessing patients with glioblastoma undergoing chemoradiation therapy. The purpose of this pilot research study is to find out if it is possible to see changes in participants' mitochondria, parts of a cell that produce energy, that might be associated with changes in participants' brain function after chemoradiation therapy.
详细描述
Primary Objective:
• To determine the feasibility of performing bioenergetic profiling in glioblastoma patients receiving chemoradiation by ascertaining the proportion of patients who have enough white blood cells in a 16 mL blood to successfully perform the profiling assays.
Secondary Objectives:
• To determine if either pre-radiotherapy bioenergetic profile or the change in bioenergetic profile from pre-radiotherapy to post-radiotherapy are predictive of subacute cognitive decline after radiation.
OUTLINE: Patients undergo neurocognitive testing over 1 hour using a customized battery of tests designed for brain tumor patients at Wake Forest Baptist Comprehensive Cancer Center. Patients also undergo blood collection at baseline and at 1 and 3 months post radiotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Glioma patients greater than 18 years old receiving chemoradiation with a Karnofsky Performance Status greater than or equal to 50.
排除标准
- •Prior diagnosis (by a physician or neuropsychologist) of any type of dementia (AD, frontotemporal dementia, vascular dementia, Lewy-body dementia, Parkinson's dementia), normal pressure hydrocephalus, Creutzfeldt Jacob disease, posterior cortical atrophy, Huntington's disease, or Korsakoff syndrome will be excluded. Patients who were diagnosed with Mild Cognitive (MCI) Impairment greater than or equal to 1 year prior to diagnosis with their high grade glioma will also be excluded. Patients reported by family members as having memory problems or with subjective memory complaints are still eligible.
- •Patients taking medications known to have a mitotoxic effect (see attached appendix). Patients who take any of the as needed medications on the list more than 4 times per week will be excluded. There are medications that are considered mitotoxic that are not included on this list because of the essential nature of the medications to this population (steroids, anti-seizure medications, diabetic medications etc.) or high frequency of use in this population (statins, beta blockers).
- •Patients on medications with the potential to enhance cognition including donepezil, memantine, armodafinil or methylphenidate.
- •Patients who are not fluent in English will be excluded.
- •Patients with aphasia or other neurologic deficit which would prevent participating in cognitive testing will be excluded.
- •Patients who are unable to fast for 8 hours will be excluded since enrolled patients will only be able to drink water for the 8 hours before blood draws.
- •Patients who drink more than 14 alcoholic drinks per week.
- •Patients who are active smokers.
结局指标
主要结局
Number of Patients Completing Bioenergetics Profiling
时间窗: 3 months
The primary outcome will be the proportion of patients who are able to have bioenergetic profiling completed at all three time points (baseline, one month after radiotherapy, three months after radiotherapy). The proportion and its 95% confidence interval will be calculated.
次要结局
- Proportion of Participants with Decline in Cognitive Function(Three months after completion of radiotherapy)
- Bioenergetics Profiling Testing - Seahorse XFe24 Analyzer(Three months after completion of radiotherapy)
- Bioenergetics Profile Testing - Oroboros O2K(Three months after completion of radiotherapy)