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Trial Title:
Effects of Different Doses of Vitamin D on Cancer-related Cognitive Impairment in Patients With Gastrointestinal Tumors
NCT ID:
NCT05552729
Condition:
Gastrointestinal Neoplasms
Cognitive Impairment
Conditions: Official terms:
Gastrointestinal Neoplasms
Digestive System Neoplasms
Cognitive Dysfunction
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Conditions: Keywords:
Gastrointestinal Neoplasms
Cognitive Impairment
Vitamin D
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Drug
Intervention name:
Vitamin D
Description:
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.
Arm group label:
High dose group
Arm group label:
Low dose group
Other name:
Different doses of vitamin D
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Daorong Wang
Address:
City:
Yangzhou
Zip:
225009
Country:
China
Start date:
September 22, 2022
Completion date:
December 30, 2022
Lead sponsor:
Agency:
Yangzhou University
Agency class:
Other
Collaborator:
Agency:
Subei People's Hospital of Jiangsu Province
Agency class:
Other
Source:
Yangzhou University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05552729
