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

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05552729
• Other study ID #: Yangzhou University
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: September 22, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: September 2022
• Source: Yangzhou University
• Contact: Daorong Wang, Professor
• Phone: 18051062590
• Email: wangdaorong666[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 114
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Digestive System Neoplasms
• Gastrointestinal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Daorong Wang	Yangzhou	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Yangzhou University	Subei People's Hospital of Jiangsu Province

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive function	Fact-cog Cognitive Scale.The higher the score, the better the cognition.	Eight days after the surgery
Secondary	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
Secondary	Cancer related fatigue	Cancer Fatigue Scale. The total score ranges from 0 to 15, and 4 is considered frailty.	Eight days after the surgery
Secondary	Asthenia	Groningen Frailty Indicator. The total score ranges from 0 to 15, and 4 is considered frailty.	Eight days after the surgery