Perioperative Application of Omega-3 Polyunsaturated Fatty Acids in Gastric Cancer Patients (PAOPUFAGC)
Primary Purpose
Gastric Cancer
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
omega-3 polyunsaturated fatty acids
Sponsored by
About this trial
This is an interventional supportive care trial for Gastric Cancer focused on measuring omega-3 gastric cancer perioperation
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
omega-3 polyunsaturated fatty acids
Arm Description
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.
Outcomes
Primary Outcome Measures
blood immune factors
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01910948
Brief Title
Perioperative Application of Omega-3 Polyunsaturated Fatty Acids in Gastric Cancer Patients
Acronym
PAOPUFAGC
Official Title
Efficacy of Perioperative Application of Omega-3 Polyunsaturated Fatty Acids on Postoperative Immunization in Gastric Cancer Patients - A Prospective, Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
March 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jian Suo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
omega-3 gastric cancer perioperation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
omega-3 polyunsaturated fatty acids
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
omega-3 polyunsaturated fatty acids
Other Intervention Name(s)
omega-3 PUFA, ω-3 PUFA
Intervention Description
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.
Primary Outcome Measure Information:
Title
blood immune factors
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
12. IPD Sharing Statement
Learn more about this trial
Perioperative Application of Omega-3 Polyunsaturated Fatty Acids in Gastric Cancer Patients
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