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

• ClinicalTrials.gov Identifier: NCT01910948
• Recruitment Status: Unknown
• First Posted: July 30, 2013
• Last Update Posted: July 30, 2013
• Sponsor: Jian Suo
• Information provided by (Responsible Party): Jian Suo, The First Hospital of Jilin University

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• 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

Contacts and Locations

No Contacts or Locations Provided

More Information

• 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
• 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:

Stomach Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases