Effect of oral nutrition supplement enriched with eicosapentaenoic acid (Prosure) on inflammatory response following colon cancer surgery: A Phase II randomized controlled study

Phase 2

• Conditions: Colon Cancer

• Registration Number: JPRN-UMIN000008434
• Lead Sponsor: agoya City University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-13
• Study Completion: 2016-06-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

1.Intestinal obstruction and enterostenosis (unable to take orally) 2.Multiple carcinoma 3.Stage III b<= and T1>= 4.Patient who is going to take abdominoperineal rectal resection 5.Patient who is going to remove other organs 6.Patient who is not going to remove the carcinoma 7.Patient who requires blood transfusion 8.BMI>=30kg/m2 9.Cardiac disease, liver failure, and renal failure 10.Steroid use 11.Antimicrobial use within 2 weeks 12.Allergic tendency 13.Allergic to the ingredients 14.Woman pregnant and /or nursing, or woman who is willing to be pregnant 15.Focus of infection 16.Chronic inflammation 17.ASA score>=3 18.Unable to provide consent 19.Chemotherapy or radiotherapy 20.Uncontrollable DM 21.Hematencephalon or subarachnoidal hemorrhage within a month 22.EPA supplement use 23.Considered inadequate for the inclusion in the study by the physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IL-6

Secondary Outcome Measures

Name	Time	Method
CRP Inflammatory markers (body temperature and WBC) Adherence Length of stay Complication rate Nutrition Status (prealbumin, weight, and hand grip) Safety and adverse effects (clinical finding and clinical data)