NCT01910948

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_4 gastric-cancer

Timeline
Completed

Started Jun 2013

Shorter than P25 for phase_4 gastric-cancer

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

July 30, 2013

Status Verified

July 1, 2013

Enrollment Period

6 months

First QC Date

July 23, 2013

Last Update Submit

July 26, 2013

Conditions

Keywords

omega-3 gastric cancer perioperation

Outcome Measures

Primary Outcomes (1)

  • blood immune factors

    10 days

Study Arms (1)

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.

Drug: omega-3 polyunsaturated fatty acids

Interventions

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.

Also known as: omega-3 PUFA, ω-3 PUFA
omega-3 polyunsaturated fatty acids

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Headmaster, Dept.of General Surgery

Study Record Dates

First Submitted

July 23, 2013

First Posted

July 30, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2013

Study Completion

March 1, 2014

Last Updated

July 30, 2013

Record last verified: 2013-07