Effect of Different Doses of Vitamin D on Cancer-related Cognitive Impairment in Patients With Gastrointestinal Tumors: a Randomized Controlled Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Cognitive function
研究概览
简要总结
To explore the effect of different doses of vitamin D drugs on gastrointestinal cancer cancer-related cognitive impairment, so as to provide reference and basis for the clinical use of our cognitive function surgery nursing plan for patients with gastrointestinal cancer.
详细描述
To determine the incidence of postoperative cognitive dysfunction in patients with gastrointestinal tumors to determine the influencing factors of postoperative cognitive dysfunction in patients with gastrointestinal tumors. The characteristics of perioperative cancer-related cognitive impairment in patients with gastrointestinal tumors were analyzed by monitoring preoperative and postoperative FACT-COG cognitive scale connection test (Hua-Shan-version auditory word learning test) DSST digit symbol test gaffes detection task and hematology indexes, such as observation and analysis of the interference pattern of supplement vitamin D preparation postoperative hospital stay in patients with gastrointestinal tumor short-term cognitive impairment related to cancer, in order to reduce the incidence of complications and hospitalization days, improve cognitive function in patients with gastrointestinal tumor surgery, and improve the quality of nursing.
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
- Single (Participant)
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
- •Patients with gastrointestinal tumors diagnosed by gastroscopy and histology and their family members
- •Elective surgery
- •Education level in primary school or above
- •Be able to fill in the questionnaire alone or under the guidance of the researcher
- •Informed consent and voluntary participation in this study
排除标准
- •Patients with cognitive impairment (illiteracy less than 17 points, primary school less than 20 points, secondary school or above less than 24 points) or previous history of cognitive impairment, dementia and delirium confirmed by MMSE examination before surgery
- •Patients with life-threatening acute and chronic diseases
- •Patients with eye or ear diseases leading to rapid loss of hearing or vision without AIDS
- •Patients who have taken drugs related to improving cognitive function or drugs for psychiatric disorders
- •Patients who cannot take care of themselves or are physically disabled and unable to perform neurological function tests
- •Intraoperative hypoxemia (blood oxygen saturation < 94％) more than 10 minutes
- •Patients who quit or died due to non-cooperation or emergency
研究组 & 干预措施
High dose group
A 2000IU vitamin D3 supplement was started the next day after surgery.
干预措施: Vitamin D (Drug)
Low dose group
A 400IU vitamin D3 supplement was started the next day after surgery.
干预措施: Vitamin D (Drug)
结局指标
主要结局
Cognitive function
时间窗: Eight days after the surgery
Fact-cog Cognitive Scale.The higher the score, the better the cognition.
次要结局
- Sleep(Eight days after the surgery)
- Cancer related fatigue(Eight days after the surgery)
- Asthenia(Eight days after the surgery)
研究者
Wang Daorong
Professor
Yangzhou University