Gastric CancerNCT03730545
Effect of Enteral Immunonutrition on Immune, Inflammatory Markers and Nutritional Status in Patients Undergoing Gastrectomy for Gastric Cancer
A study testing enteral immunonutrition in people with Gastric Cancer and Enteral Immunonutrition, run by West China Hospital.
Trial summary
Enteral immunonutrition (EIN) has been gaining increasing attention, but data of its immune and anti-inflammatory function in patients undergoing gastrectomy for gastric cancer are poorly investigated. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer, Enteral Immunonutrition
- What is being tested?
- enteral immunonutrition
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 20 Sep 2018
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 80 years
- with histologically diagnosed cancer of stomach
- candidates for elective subtotal or total gastrectomy
Who cannot join
- pregnant or lactating woman,
- diagnoses of mental diseases
- resent severe concomitant diseases (chronic cardiopulmonary disease, chronic renal failure, etc.)
- known allergies to nutrition formula or component
- drug intolerance
- known immunodeficiency or autoimmune diseases
About this study
Official title: Effect of Enteral Immunonutrition on Immune, Inflammatory Markers and Nutritional Status in Patients Undergoing Gastrectomy for Gastric Cancer：a Randomized Double Blinded Controlled Trial
Enteral immunonutrition (EIN) has been gaining increasing attention, but data of its immune and anti-inflammatory function in patients undergoing gastrectomy for gastric cancer are poorly investigated. The aim of this study was to assess the effect of EIN on immune function, inflammation response and nutrition status when compared to standard enteral nutrition (SEN).
The investigators believe that the proportion of cluster of differentiation 4 T-cells(CD4＋T-cells), cluster of differentiation 3 T-cells(CD3＋T-cells) and the counts of CD4＋ / cluster of differentiation 8 T-cells (CD8＋), immunoglobulin G(IgG), immunoglobulin M(IgM), and immunoglobulin A (IgA) were larger in EIN group, while the level of WBC, CRP and TNF-α were lower and nutritional status was similar.
- Conditions
- Gastric Cancer, Enteral Immunonutrition
- Being tested
- enteral immunonutrition
- Keywords
- gastric cancer, enteral nutrition, enteral immunonutrition, immune function, inflammation response
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteral immunonutritionDietary supplement
Enteral nutrition was started within 12h at an infusion rate of 20ml per hour for SEN group and 16ml per hour for EIN group in the first 24h. The rates of flow were gradually increasing with 50ml/h in SEN versus 40ml/h in EIN on day 2, 70ml/h versus 56ml/h on day 3 and 100ml/h versus 80ml/h until the 7th day depending on the feeding tolerance.
| Study group | Role | What they receive |
|---|---|---|
| EIN group | Experimental | Enteral formula including not only basic energy components, but also immune components such as omega-3 fatty acids, glutamine (Gln), arginine (Arg), and nucleotide. Receives: Dietary Supplement: enteral immunonutrition |
| SEN group | Active comparator | Enteral formula including only basic energy components. Receives: Dietary Supplement: enteral immunonutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline serum level of immune cytokines to postoperative day 5
levels of IgA, IgG and IgM in g/L,
Measured: baseline and postoperative day 5
Change from baseline serum level of immune markers to postoperative day 5
count of CD4＋/CD8＋
Measured: baseline, postoperative day 5(POD 5)
Change from baseline serum concentration of immune markers to postoperative day 5
percentage of CD3＋ T cell of serum
Measured: baseline, postoperative day 5(POD 5)
Secondary outcomes (2)
changes among baseline, postoperative day 1, 3 and 5 serum concentration of inflammatory markers
concentration of white blood cell (WBC), C-reactive protein (CRP), interleukin-6 (IL-6) in g/L, and levels of tumor necrosis factor-α (TNF-α) in ng/L
Measured: baseline, postoperative day 1, 3, and 5
Change among baseline, postoperative day 3 and 5 serum nutritional markers
concentration of albumin, prealbumin, and transferrin in g/L
Measured: baseline,postoperative day 3 and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start1 Jan 2017
- Primary completion1 Jul 2018
- Study completion20 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomized to receive enteral immunonutrition or standard enteral nutrition in postoperative day 1 by enteral feeding.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong Zhou, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730545
- Sponsor's protocol ID
- 396312366
- Status last verified
- Nov 2018
- First submitted
- 25 Oct 2018
- Last updated
- 5 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Enteral Immunonutrition on Immune, Inflammatory Markers and Nutritional Status in Patients Undergoing Gastrectomy for Gastric Cancer：a Randomized Double Blinded Controlled Trial
- ClinicalTrials.gov ID
- NCT03730545
- Acronym / sponsor ID
- 396312366
- Conditions
- Gastric Cancer, Enteral Immunonutrition
- Keywords
- gastric cancer, enteral nutrition, enteral immunonutrition, immune function, inflammation response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 20 Sep 2018 (actual)
- First posted
- 5 Nov 2018 (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.
Enteral immunonutrition (EIN) has been gaining increasing attention, but data of its immune and anti-inflammatory function in patients undergoing gastrectomy for gastric cancer are poorly investigated. The aim of this study was to assess the effect of EIN on immune function, inflammation response and nutrition status when compared to standard enteral nutrition (SEN).
The investigators believe that the proportion of cluster of differentiation 4 T-cells(CD4＋T-cells), cluster of differentiation 3 T-cells(CD3＋T-cells) and the counts of CD4＋ / cluster of differentiation 8 T-cells (CD8＋), immunoglobulin G(IgG), immunoglobulin M(IgM), and immunoglobulin A (IgA) were larger in EIN group, while the level of WBC, CRP and TNF-α were lower and nutritional status was similar.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients were randomized to receive enteral immunonutrition or standard enteral nutrition in postoperative day 1 by enteral feeding.
| Arm | Type | Receives |
|---|---|---|
| EIN group | Experimental | Dietary Supplement: enteral immunonutritionEnteral formula including not only basic energy components, but also immune components such as omega-3 fatty acids, glutamine (Gln), arginine (Arg), and nucleotide. |
| SEN group | Active comparator | Dietary Supplement: enteral immunonutritionEnteral formula including only basic energy components. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 to 80 years
- with histologically diagnosed cancer of stomach
- candidates for elective subtotal or total gastrectomy
Key exclusion criteria (6 listed)
- pregnant or lactating woman,
- diagnoses of mental diseases
- resent severe concomitant diseases (chronic cardiopulmonary disease, chronic renal failure, etc.)
- known allergies to nutrition formula or component
- drug intolerance
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 |
|---|---|---|
| enteral immunonutritionEnteral nutrition was started within 12h at an infusion rate of 20ml per hour for SEN group and 16ml per hour for EIN group in the first 24h. The rates of flow were gradually increasing with 50ml/h in SEN versus 40ml/h in EIN on day 2, 70ml/h versus 56ml/h on day 3 and 100ml/h versus 80ml/h until the 7th day depending on the feeding tolerance. | Dietary supplement | EIN group, SEN group |
Primary outcome
Change from baseline serum level of immune cytokines to postoperative day 5
Time frame: baseline and postoperative day 5
levels of IgA, IgG and IgM in g/L,
Change from baseline serum level of immune markers to postoperative day 5
Time frame: baseline, postoperative day 5(POD 5)
count of CD4＋/CD8＋
Change from baseline serum concentration of immune markers to postoperative day 5
Time frame: baseline, postoperative day 5(POD 5)
percentage of CD3＋ T cell of serum
2 secondary outcomes
changes among baseline, postoperative day 1, 3 and 5 serum concentration of inflammatory markers
Time frame: baseline, postoperative day 1, 3, and 5
Change among baseline, postoperative day 3 and 5 serum nutritional markers
Time frame: baseline,postoperative day 3 and 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing enteral immunonutrition in people with Gastric Cancer and Enteral Immunonutrition, run by West China Hospital.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 5 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline serum level of immune cytokines to postoperative day 5 (time frame: baseline and postoperative day 5). The study lists 3 primary outcomes in all. 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 5 Nov 2018.