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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008434

Enrollment

100

Registered

2012-07-13

Start date

2012-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

Interventions

Oral supplementation of 2 packs of Prosure per day for 14days before colon cancer surgery Prosure is not ingested

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically proven colon cancer 2.Laparoscopic excision 3.Written informed consent 4.Age ranging between 20 and 79 years old 5.Oral intake 6.CRP>=0.5mg/dL 7.Function of main organs is well preserved

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
IL-6	—

Secondary

Measure	Time frame
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)	—

Countries

Japan

Contacts

Public ContactNanami Sato

Japanese Society for Cancer Nutrition Therapy Secretariat

jscan@jeff.co.jp03-3578-0303

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026