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

Sponsor

Yangzhou University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05552729

Collaborator

Subei People's Hospital of Jiangsu Province (Other)

114

Enrollment

Location

Arms

3.3

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Neoplasms Cognitive Impairment	Drug: Vitamin D	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

114 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 22, 2022

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: High dose group A 2000IU vitamin D3 supplement was started the next day after surgery.	Drug: Vitamin D 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. Other Names: Different doses of vitamin D
Active Comparator: Low dose group A 400IU vitamin D3 supplement was started the next day after surgery.	Drug: Vitamin D 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. Other Names: Different doses of vitamin D
No Intervention: The control group. No vitamin D3 supplement was started the next day after surgery.

Arm

Intervention/Treatment

Active Comparator: High dose group

A 2000IU vitamin D3 supplement was started the next day after surgery.

Drug: Vitamin D

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.

Other Names:

Different doses of vitamin D

Active Comparator: Low dose group

A 400IU vitamin D3 supplement was started the next day after surgery.

Drug: Vitamin D

Other Names:

Different doses of vitamin D

No Intervention: The control group.

No vitamin D3 supplement was started the next day after surgery.

Outcome Measures

Primary Outcome Measures

Cognitive function [Eight days after the surgery]
Fact-cog Cognitive Scale.The higher the score, the better the cognition.

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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