Effects of Different Doses of Vitamin D on Cancer-related Cognitive Impairment in Patients With Gastrointestinal Tumors
- Conditions
- Gastrointestinal NeoplasmsCognitive Impairment
- Interventions
- Registration Number
- NCT05552729
- Lead Sponsor
- Yangzhou University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 114
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High dose group Vitamin D A 2000IU vitamin D3 supplement was started the next day after surgery. Low dose group Vitamin D A 400IU vitamin D3 supplement was started the next day after surgery.
- Primary Outcome Measures
Name Time Method Cognitive function Eight days after the surgery Fact-cog Cognitive Scale.The higher the score, the better the cognition.
- Secondary Outcome Measures
Name Time Method Sleep Eight days after the surgery Pittsburgh sleep quality index.The overall score ranges from 0 to 21, with a score of 0 to 5 indicating good sleep quality,6 to 10 indicating fair sleep quality,11 to 15 indicating fair sleep quality, and 16 to 21 indicating very poor sleep quality.
Cancer related fatigue Eight days after the surgery Cancer Fatigue Scale. The total score ranges from 0 to 15, and 4 is considered frailty.
Asthenia Eight days after the surgery Groningen Frailty Indicator. The total score ranges from 0 to 15, and 4 is considered frailty.
Trial Locations
- Locations (1)
Daorong Wang
🇨🇳Yangzhou, Jiangsu, China