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Perioperative Application of Omega-3 Polyunsaturated Fatty Acids in Gastric Cancer Patients (PAOPUFAGC)

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ClinicalTrials.gov Identifier: NCT01910948
Recruitment Status : Unknown
Verified July 2013 by Jian Suo, The First Hospital of Jilin University.
Recruitment status was:  Active, not recruiting
First Posted : July 30, 2013
Last Update Posted : July 30, 2013
Sponsor:
Information provided by (Responsible Party):
Jian Suo, The First Hospital of Jilin University

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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: omega-3 polyunsaturated fatty acids Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
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 Start Date : June 2013
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: omega-3 polyunsaturated fatty acids
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.
Drug: omega-3 polyunsaturated fatty acids
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.
Other Names:
  • omega-3 PUFA
  • ω-3 PUFA




Primary Outcome Measures :
  1. blood immune factors [ Time Frame: 10 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Responsible Party: Jian Suo, Headmaster, Dept.of General Surgery, The First Hospital of Jilin University
ClinicalTrials.gov Identifier: NCT01910948    
Other Study ID Numbers: omega-3 PUFA
First Posted: July 30, 2013    Key Record Dates
Last Update Posted: July 30, 2013
Last Verified: July 2013
Keywords provided by Jian Suo, The First Hospital of Jilin University:
omega-3 gastric cancer perioperation
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases