Overview

This trial is active, not recruiting.

Condition gastric cancer
Treatment omega-3 polyunsaturated fatty acids
Phase phase 4
Sponsor Jian Suo
Start date June 2013
End date December 2013
Trial size 100 participants
Trial identifier NCT01910948, omega-3 PUFA

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking single blind (subject)
Primary purpose supportive care
Arm
(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.
omega-3 polyunsaturated fatty acids omega-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.

Primary Outcomes

Measure
blood immune factors
time frame: 10 days

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title Efficacy of Perioperative Application of Omega-3 Polyunsaturated Fatty Acids on Postoperative Immunization in Gastric Cancer Patients - A Prospective, Randomized Clinical Trial
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by First Hospital of Jilin University.