The Memory Preservation Study of Whole Brain Radiotherapy With Hippocampal Avoidance for Patients With Brain Metastases
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes of Memory immediate recall and delayed recall
研究概览
简要总结
The study aimed to investigate the memory preservation and neurocognitive function protection of hippocampal avoidance whole brain radiotherapy (HA-WBRT) among people who speak Mandarin Chinese or Taiwanese.
详细描述
Brain metastasis is very common, about 30% incidence rate for all patients with a diagnosis of cancer. The rising incidence of brain metastasis is most likely due to recent advances in systemic therapy, and use of magnetic resonance imaging (MRI). The most common primary site is the lung followed by breast. One of the standard treatments is whole brain radiotherapy; it can prolong the decline of neurocognitive function and improve quality of life. However, it can also cause decline in neurocognitive function as a late sequela. Memory impairment is the main cognitive function that affected by radiotherapy, and the neuronal stem cells located at hippocampal subgranular zone are highly sensitive to radiotherapy. There have been large randomized trials confirming that by HA-WBRT, the neurocognitive function decline can be reclaimed. In Taiwan, HA-WBRT is a popular and emerging treatment. However, not much study focused on its effects on neurocognitive function. The study is aimed to objectively investigate the memory preservation and neurocognitive function protection of HA-WBRT in people speaking Mandarin Chinese or Taiwanese by utilizing neurocognitive function test and QoL questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with brain metastases, the brain metastases are located 5mm outside the hippocampus
- •Pathologically proven diagnosis of nonhematopoietic malignancy other than germ cell malignancy
- •No psychologic disorders
- •Radiation Therapy Oncology Group recursive partitioning analysis class I or II
- •First or second language: Mandarin Chinese or Taiwanese
- •Signed the inform consensus
排除标准
- •Less than 20 years old
- •Leptomeningeal metastases or hydrocephalus
- •Previous radiotherapy to head and neck region
- •Creatinine >1.5mg/dl
- •More than 2 extracranial metastases
- •Patients who cannot tolerate memory or neurocognitive function test or cannot complete QoL questionnaire
研究组 & 干预措施
HA-WBRT
Patients with brain metastases outside a 5-mm margin around either hippocampus and are eligible to this study will receive hippocampal avoidance whole brain radiotherapy 30 gray (Gy) in 10 fractions. The primary endpoint is Wechsler Memory Scale (Chinese) and cognitive abilities screening instrument (CASI) at 4 months.
干预措施: Hippocampal avoidance whole brain radiotherapy (Radiation)
结局指标
主要结局
Changes of Memory immediate recall and delayed recall
时间窗: From baseline to 4 months after RT complete, tests are performed at baseline before radiotherapy begins, 2 months after radiotherapy complete and 4 months after radiotherapy complete.
The memory battery is using Wechsler Memory Scale (Chinese), including Logical Memory I \& II, Word Lists Ⅰ \& II, Faces Ⅰ and spatial span.
Changes of general cognitive function
时间窗: From baseline to 4 months after RT complete, tests are performed at baseline before radiotherapy begins, 2 months after radiotherapy complete and 4 months after radiotherapy complete.
General cognitive function are tested using cognitive abilities screening instrument, CASI for screening and to test cognitive function as a whole.
次要结局
- Changes of Quality of life(From baseline to 4 months after RT complete, the participants are requested to fill in the questionnaire of quality of life at baseline before radiotherapy begins, and 2 months after radiotherapy complete and 4 months after radiotherapy complete.)