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

Primary Purpose

Gastrointestinal Neoplasms, Cognitive Impairment

Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
Yangzhou University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Neoplasms focused on measuring Gastrointestinal Neoplasms, Cognitive Impairment, Vitamin D

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Daorong Wang

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

High dose group

Low dose group

The control group.

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Cognitive function
Fact-cog Cognitive Scale.The higher the score, the better the cognition.

Secondary Outcome Measures

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.
Cancer related fatigue
Cancer Fatigue Scale. The total score ranges from 0 to 15, and 4 is considered frailty.
Asthenia
Groningen Frailty Indicator. The total score ranges from 0 to 15, and 4 is considered frailty.

Full Information

First Posted
September 3, 2022
Last Updated
September 20, 2022
Sponsor
Yangzhou University
Collaborators
Subei People's Hospital of Jiangsu Province
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1. Study Identification

Unique Protocol Identification Number
NCT05552729
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 22, 2022 (Anticipated)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yangzhou University
Collaborators
Subei People's Hospital of Jiangsu Province

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Neoplasms, Cognitive Impairment
Keywords
Gastrointestinal Neoplasms, Cognitive Impairment, Vitamin D

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High dose group
Arm Type
Active Comparator
Arm Description
A 2000IU vitamin D3 supplement was started the next day after surgery.
Arm Title
Low dose group
Arm Type
Active Comparator
Arm Description
A 400IU vitamin D3 supplement was started the next day after surgery.
Arm Title
The control group.
Arm Type
No Intervention
Arm Description
No vitamin D3 supplement was started the next day after surgery.
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Other Intervention Name(s)
Different doses of vitamin D
Intervention 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.
Primary Outcome Measure Information:
Title
Cognitive function
Description
Fact-cog Cognitive Scale.The higher the score, the better the cognition.
Time Frame
Eight days after the surgery
Secondary Outcome Measure Information:
Title
Sleep
Description
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.
Time Frame
Eight days after the surgery
Title
Cancer related fatigue
Description
Cancer Fatigue Scale. The total score ranges from 0 to 15, and 4 is considered frailty.
Time Frame
Eight days after the surgery
Title
Asthenia
Description
Groningen Frailty Indicator. The total score ranges from 0 to 15, and 4 is considered frailty.
Time Frame
Eight days after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daorong Wang, Professor
Phone
18051062590
Email
wangdaorong666@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daorong Wang, Professor
Organizational Affiliation
Yangzhou University
Official's Role
Study Director
Facility Information:
Facility Name
Daorong Wang
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225009
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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