Effects of Different Doses of Vitamin D on Cancer-related Cognitive Impairment in Patients With Gastrointestinal Tumors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Different Doses of Vitamin D on Cancer-related Cognitive Impairment in Patients With Gastrointestinal Tumors: a Randomized Controlled Study

Conditions
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Gastrointestinal Neoplasms, Cognitive Impairment

Intervention / Treatment
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* Drug: Vitamin D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High dose group<br>A 2000IU vitamin D3 supplement was started the next day after surgery. | Drug: Vitamin D<br>* The patients were given vitamin D supplementation 48 hours after surgery, and the two groups were given different doses of vitamin D supplementation until the postoperative discharge criteria were met. To scientifically evaluate the application effect of early postoperative vitamin D intervention in the improvement of perioperative cognitive function in patients with gastrointestinal tumors.<br>* Other names: Different doses of vitamin D;|
| Active Comparator: Low dose group<br>A 400IU vitamin D3 supplement was started the next day after surgery. | Drug: Vitamin D<br>* The patients were given vitamin D supplementation 48 hours after surgery, and the two groups were given different doses of vitamin D supplementation until the postoperative discharge criteria were met. To scientifically evaluate the application effect of early postoperative vitamin D intervention in the improvement of perioperative cognitive function in patients with gastrointestinal tumors.<br>* Other names: Different doses of vitamin D;|
| No Intervention: The control group.<br>No vitamin D3 supplement was started the next day after surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function | Fact-cog Cognitive Scale.The higher the score, the better the cognition. | Eight days after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep | 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. | Eight days after the surgery | 
| Cancer related fatigue | Cancer Fatigue Scale. The total score ranges from 0 to 15, and 4 is considered frailty. | Eight days after the surgery | 
| Asthenia | Groningen Frailty Indicator. The total score ranges from 0 to 15, and 4 is considered frailty. | Eight days after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrointestinal Neoplasms, Cognitive Impairment, Vitamin D