Gastrointestinal NeoplasmsPhase 1/2NCT05552729
Effects of Different Doses of Vitamin D on Cancer-related Cognitive Impairment in Patients With Gastrointestinal Tumors
A Phase 1/2 study testing Vitamin D in people with Gastrointestinal Neoplasms and Cognitive Impairment, run by Yangzhou University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Neoplasms, Cognitive Impairment
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- 22 Sep 2022to 30 Dec 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastrointestinal Neoplasms, Cognitive Impairment
- Being tested
- Vitamin D
- Keywords
- Gastrointestinal Neoplasms, Cognitive Impairment, Vitamin D
- Medical subject headings
- Gastrointestinal Neoplasms, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Also called Different doses of 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.
| Study group | Role | What they receive |
|---|---|---|
| High dose group | Active comparator | A 2000IU vitamin D3 supplement was started the next day after surgery. Receives: Drug: Vitamin D |
| Low dose group | Active comparator | A 400IU vitamin D3 supplement was started the next day after surgery. Receives: Drug: Vitamin D |
| The control group. | No intervention | No vitamin D3 supplement was started the next day after surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
Fact-cog Cognitive Scale.The higher the score, the better the cognition.
Measured: Eight days after the surgery
Secondary outcomes (3)
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.
Measured: Eight days after the surgery
Cancer related fatigue
Cancer Fatigue Scale. The total score ranges from 0 to 15, and 4 is considered frailty.
Measured: Eight days after the surgery
Asthenia
Groningen Frailty Indicator. The total score ranges from 0 to 15, and 4 is considered frailty.
Measured: Eight days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start22 Sep 2022 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yangzhou University
- Sponsor type
- University, hospital or other
- Collaborators
- Subei People's Hospital of Jiangsu Province
- Responsible party
- Principal investigator, Wang Daorong, Yangzhou University
- Investigators
- Daorong Wang, Professor, Study director, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552729
- Sponsor's protocol ID
- Yangzhou University
- Status last verified
- Sep 2022
- First submitted
- 3 Sep 2022
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Doses of Vitamin D on Cancer-related Cognitive Impairment in Patients With Gastrointestinal Tumors: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05552729
- Acronym / sponsor ID
- Yangzhou University
- Conditions
- Gastrointestinal Neoplasms, Cognitive Impairment
- Keywords
- Gastrointestinal Neoplasms, Cognitive Impairment, Vitamin D
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Yangzhou UniversityUniversity, hospital or other
- Collaborators
- Subei People's Hospital of Jiangsu Province
- Study start
- 22 Sep 2022 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High dose group | Active comparator | Drug: Vitamin DA 2000IU vitamin D3 supplement was started the next day after surgery. |
| Low dose group | Active comparator | Drug: Vitamin DA 400IU vitamin D3 supplement was started the next day after surgery. |
| The control group. | No intervention | –No vitamin D3 supplement was started the next day after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DAlso: Different doses of vitamin DThe 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. | Drug | High dose group, Low dose group |
Primary outcome
Cognitive function
Time frame: Eight days after the surgery
Fact-cog Cognitive Scale.The higher the score, the better the cognition.
3 secondary outcomes
Sleep
Time frame: Eight days after the surgery
Cancer related fatigue
Time frame: Eight days after the surgery
Asthenia
Time frame: Eight days after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daorong Wang, Professor study director
Yangzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vitamin D in people with Gastrointestinal Neoplasms and Cognitive Impairment, run by Yangzhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daorong Wang, Professor (18051062590, wangdaorong666@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function (time frame: Eight days after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2022; AzTrials last refreshed its copy on 8 Nov 2026.