Gastric CancerPhase 4PAOPUFAGCNCT01910948
Perioperative Application of Omega-3 Polyunsaturated Fatty Acids in Gastric Cancer Patients
A Phase 4 study testing omega-3 polyunsaturated fatty acids in people with Gastric Cancer, run by Jian Suo.
Trial summary
To evaluate immunomodulatory effects of perioperative application of omega-3 polyunsaturated fatty acids in gastric cancer surgery, the effects of postoperative recovery, the improvement of nutritional status, incidence rate of related complications, and whether it can reduce the average postoperative hospitalization… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- omega-3 polyunsaturated fatty acids
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Mar 2014
- Phase
- Phase 4
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients coming to FirstJilinU diagnosed gastric cancer by endoscopy and pathology.
- No preoperative treatment, the gastric cancer radical surgery in our hospital is the first treatment.
- Nutrition screening score (NRS 3 or higher).
- Albumin and (or) immune enhancer were not used within two weeks before operation .
- No blood system diseases.
Who cannot join
- Being in the acute phase of inflammation before operation and emergency surgery.
- Patients combined metabolic diseases such as diabetes, hyperthyroidism, immune system disease or taking immunosuppressants;
- Combined hepatic insufficiency.
- Spleen resected in operation
About this study
Official title: Efficacy of Perioperative Application of Omega-3 Polyunsaturated Fatty Acids on Postoperative Immunization in Gastric Cancer Patients - A Prospective, Randomized Clinical Trial
To evaluate immunomodulatory effects of perioperative application of omega-3 polyunsaturated fatty acids in gastric cancer surgery, the effects of postoperative recovery, the improvement of nutritional status, incidence rate of related complications, and whether it can reduce the average postoperative hospitalization days.
Read the detailed description
Methods: Choose from 6 to 2013-2013-12 gastric cancer patients, according to inclusion criteriaS to choose the objectS of study from the gastric cancer patients coming to our hospital 2013-06 to 2013-12 .The included patients will be randomly divided into two groups A and B, two groups of patients 4 days before operation begin to give parenteral nutrition: A: the control group of normal intravenous nutrition. B: the trial group,add Omega-3 Polyunsaturated Fatty Acids 0.2 g/kg to parenteral nutrition, no use on the day of surgery, postoperative 2 days continue to add Omega-3 Polyunsaturated Fatty Acids 0.2 g/kg. Detect and compare CRP、TNF-α、IL-1、IL-4、lL-6、 IL-8、lL-10 levels of two groups in days before parenteral nutrition and applicating 3rd day and postoperative 1st, 3rd, 5th,and detect liver function in preoperative and postoperative 2nd,5th,7th day. Record postoperative anal exhaust time, postoperative complications, postoperative hospital days, preoperative and postoperative body weight.Results: Trail group patients compared with the control group,Omega-3 Polyunsaturated Fatty Acids can reduce early postoperative inflammatory cytokines release, reduce the postoperative fever time, reduce the incidence of systemic inflammatory response syndrome, promote the recovery of gastrointestinal function, improve the nutritional state of patients, reduce infection and related complications after the surgery and reduce postoperative hospitalization days. Conclusions: Perioperative application of omega 3 PUFA can reduce the release of inflammatory cytokines, regulating cell and humoral immunity, reduce the postoperative fever time, reduce the local inflammation medium that inhibit the gastrointestinal peristalsis, promote the recovery of gastrointestinal function, improve the nutritional state of patients, thereby reducing the occurrence of postoperative infection and related complications, reduce postoperative hospitalization days.
- Conditions
- Gastric Cancer
- Being tested
- omega-3 polyunsaturated fatty acids
- Keywords
- omega-3 gastric cancer perioperation
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega-3 polyunsaturated fatty acidsDrug
Also called omega-3 PUFA, ω-3 PUFA
The included patients will be randomly divided into two groups A and B, two groups of patients 4 days before operation begin to give parenteral nutrition: A: the control group of normal intravenous nutrition. B: the trial group,add omega-3 polyunsaturated fatty acids 0.2 g/kg to parenteral nutrition, no use on the day of surgery, postoperative 2 days continue to add omega-3 polyunsaturated fatty acids 0.2 g/kg.
| Study group | Role | What they receive |
|---|---|---|
| omega-3 polyunsaturated fatty acids | Experimental | The included patients will be randomly divided into two groups A and B, two groups of patients 4 days before operation begin to give parenteral nutrition: A: the control group of normal intravenous nutrition. B: the trial group,add omega-3 polyunsaturated fatty acids 0.2 g/kg to parenteral nutrition, no use on the day of surgery, postoperative 2 days continue to add omega-3 polyunsaturated fatty acids 0.2 g/kg. Receives: Drug: omega-3 polyunsaturated fatty acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood immune factors
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2013 (estimated)
- Study completionMar 2014 (estimated)
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.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jian Suo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jian Suo, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910948
- Sponsor's protocol ID
- omega-3 PUFA
- Acronym
- PAOPUFAGC
- Status last verified
- Jul 2013
- First submitted
- 23 Jul 2013
- Last updated
- 30 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Perioperative Application of Omega-3 Polyunsaturated Fatty Acids on Postoperative Immunization in Gastric Cancer Patients - A Prospective, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01910948
- Acronym / sponsor ID
- PAOPUFAGC / omega-3 PUFA
- Conditions
- Gastric Cancer
- Keywords
- omega-3 gastric cancer perioperation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jian SuoUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 30 Jul 2013 (estimated)
- 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 evaluate immunomodulatory effects of perioperative application of omega-3 polyunsaturated fatty acids in gastric cancer surgery, the effects of postoperative recovery, the improvement of nutritional status, incidence rate of related complications, and whether it can reduce the average postoperative hospitalization days.
Detailed description
Methods: Choose from 6 to 2013-2013-12 gastric cancer patients, according to inclusion criteriaS to choose the objectS of study from the gastric cancer patients coming to our hospital 2013-06 to 2013-12 .The included patients will be randomly divided into two groups A and B, two groups of patients 4 days before operation begin to give parenteral nutrition: A: the control group of normal intravenous nutrition. B: the trial group,add Omega-3 Polyunsaturated Fatty Acids 0.2 g/kg to parenteral nutrition, no use on the day of surgery, postoperative 2 days continue to add Omega-3 Polyunsaturated Fatty Acids 0.2 g/kg. Detect and compare CRP、TNF-α、IL-1、IL-4、lL-6、 IL-8、lL-10 levels of two groups in days before parenteral nutrition and applicating 3rd day and postoperative 1st, 3rd, 5th,and detect liver function in preoperative and postoperative 2nd,5th,7th day. Record postoperative anal exhaust time, postoperative complications, postoperative hospital days, preoperative and postoperative body weight.Results: Trail group patients compared with the control group,Omega-3 Polyunsaturated Fatty Acids can reduce early postoperative inflammatory cytokines release, reduce the postoperative fever time, reduce the incidence of systemic inflammatory response syndrome, promote the recovery of gastrointestinal function, improve the nutritional state of patients, reduce infection and related complications after the surgery and reduce postoperative hospitalization days. Conclusions: Perioperative application of omega 3 PUFA can reduce the release of inflammatory cytokines, regulating cell and humoral immunity, reduce the postoperative fever time, reduce the local inflammation medium that inhibit the gastrointestinal peristalsis, promote the recovery of gastrointestinal function, improve the nutritional state of patients, thereby reducing the occurrence of postoperative infection and related complications, reduce postoperative hospitalization days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| omega-3 polyunsaturated fatty acids | Experimental | Drug: omega-3 polyunsaturated fatty acidsThe included patients will be randomly divided into two groups A and B, two groups of patients 4 days before operation begin to give parenteral nutrition: A: the control group of normal intravenous nutrition. B: the trial group,add omega-3 polyunsaturated fatty acids 0.2 g/kg to parenteral nutrition, no use on the day of surgery, postoperative 2 days continue to add omega-3 polyunsaturated fatty acids 0.2 g/kg. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients coming to FirstJilinU diagnosed gastric cancer by endoscopy and pathology.
- No preoperative treatment, the gastric cancer radical surgery in our hospital is the first treatment.
- Nutrition screening score (NRS 3 or higher).
- Albumin and (or) immune enhancer were not used within two weeks before operation .
- No blood system diseases.
Key exclusion criteria (4 listed)
- Being in the acute phase of inflammation before operation and emergency surgery.
- Patients combined metabolic diseases such as diabetes, hyperthyroidism, immune system disease or taking immunosuppressants;
- Combined hepatic insufficiency.
- Spleen resected in operation
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 |
|---|---|---|
| omega-3 polyunsaturated fatty acidsAlso: omega-3 PUFA, ω-3 PUFAThe included patients will be randomly divided into two groups A and B, two groups of patients 4 days before operation begin to give parenteral nutrition: A: the control group of normal intravenous nutrition. B: the trial group,add omega-3 polyunsaturated fatty acids 0.2 g/kg to parenteral nutrition, no use on the day of surgery, postoperative 2 days continue to add omega-3 polyunsaturated fatty acids 0.2 g/kg. | Drug | omega-3 polyunsaturated fatty acids |
Primary outcome
blood immune factors
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2013.
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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 Phase 4 study testing omega-3 polyunsaturated fatty acids in people with Gastric Cancer, run by Jian Suo.
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 4 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 30 Jul 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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?
blood immune factors (time frame: 10 days). 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 30 Jul 2013.