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

Yangzhou University

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Cognitive Impairment; Gastrointestinal Neoplasms

Treatments: Drug: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT05552729

Yangzhou University

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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114 participants in 3 patient groups

High dose group

Active Comparator group

Description:

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

Treatment:

Drug: Vitamin D

Low dose group

Active Comparator group

Description:

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

Treatment:

Drug: Vitamin D

The control group.

No Intervention group

Description:

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