Clinical trial NCT05552729: Effects of Different Doses of Vitamin D on Cancer-related Cognitive Impairment in Patients With Gastrointestinal Tumors
Official title: Effect of Different Doses of Vitamin D on Cancer-related Cognitive Impairment in Patients With Gastrointestinal Tumors: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Gastrointestinal Neoplasms
Cognitive Impairment
Keywords: Gastrointestinal Neoplasms
Cognitive Impairment
Vitamin D
Lead sponsor: Yangzhou University
Sponsor class: OTHER
Collaborators: name: Subei People's Hospital of Jiangsu Province
First posted: 2022-09-23
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Cognitive function
timeFrame: Eight days after the surgery
Secondary outcomes:
measure: Sleep
timeFrame: Eight days after the surgery
measure: Cancer related fatigue
timeFrame: Eight days after the surgery
measure: Asthenia
timeFrame: Eight days after the surgery
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Daorong Wang
state: Jiangsu
Study officials:
affiliation: Yangzhou University
name: Daorong Wang, Professor
role: STUDY_DIRECTOR
References: