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

September 20, 2022 updated by: Wang Daorong, Yangzhou University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

114

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Yangzhou, Jiangsu, China, 225009
        • Daorong Wang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive function
Time Frame: Eight days after the surgery
Fact-cog Cognitive Scale.The higher the score, the better the cognition.
Eight days after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep
Time Frame: 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.
Eight days after the surgery
Cancer related fatigue
Time Frame: Eight days after the surgery
Cancer Fatigue Scale. The total score ranges from 0 to 15, and 4 is considered frailty.
Eight days after the surgery
Asthenia
Time Frame: Eight days after the surgery
Groningen Frailty Indicator. The total score ranges from 0 to 15, and 4 is considered frailty.
Eight days after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yangzhou University

Collaborators

Subei People's Hospital of Jiangsu Province

Investigators

  • Study Director: Daorong Wang, Professor, Yangzhou University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 22, 2022

Primary Completion (ANTICIPATED)

December 30, 2022

Study Completion (ANTICIPATED)

December 30, 2022

Study Registration Dates

First Submitted

September 3, 2022

First Submitted That Met QC Criteria

September 20, 2022

First Posted (ACTUAL)

September 23, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 23, 2022

Last Update Submitted That Met QC Criteria

September 20, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Yangzhou University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastrointestinal Neoplasms

Clinical Trials on Vitamin D

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe