PeRioperative Omega Three and the Effect on ImmuNity

NCT03598413 | Completed

• 1 other identifier: 18SURN238410
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Bowel cancer is the second most common cause of cancer-related death in the UK, with 50,000 new cases and over 15,000 deaths annually. Surgery is the mainstay of treatment and the most common complications are an infection of the wound or lungs. These can lengthen hospital stay, reduce the quality of life, and even increase the risk of death. Bowel cancer patients are often malnourished. Optimising nutrition with supplements such as fish-oils can improve the immune response of patients, helping prevent such complications, shorten hospital stay, improve quality of life and overall survival.

Conditions

Colorectal Cancer; Nutritional Deficiency; Infected Wound; Surgical Site Infection; Complication, Postoperative; Surgery; Surgery--Complications; Sarcopenia; Phagocytic Dysfunction

Keywords

enhanced recovery; perioperative nutrition; macrophages; omega 3 fatty acids

Outcome Measures

Primary Outcomes (2)

• Changes in Phagocytosis of pathogens

  Phagocytosis of E.Coli, S.Aureus and Candida measured with flow cytometry

  Baseline [2-4 weeks before surgery], Day of Surgery [day 7 post nutritional supplementation], Day 1 post surgery [day 8 post supplementation].

• Changes in cell membrane composition

  Using gas chromatography, measuring the percentage of omega-3 within cell membranes

  Baseline [2-4 weeks before surgery], Day of Surgery [day 7 post nutritional supplementation], Day 1 post surgery [day 8 post supplementation].

Secondary Outcomes (6)

• Infectious complications

  30 days

• Non-infectious complications

  30 days

• Length of hospital stay

  A maximum of 90 days

• Sarcopenia

  Baseline [Pre-operative staging CT scan] and 6 month +/-2 months

• Quality of Life (EORTC: QLQC30)

  Baseline and 3 weeks post surgery +/- 7 days

Study Arms (2)

Control

NO INTERVENTION

Patients undergoing standard laparoscopic colorectal resection with no omega-3 enriched peri-operative nutritional support

Omega-3

EXPERIMENTAL

Patients in this group will receive 7 days pre and 7 days post surgery of a nutritional supplement enriched with 1.42g/dose of the fish oils EPA and DHA. The supplement is pre-mixed and will be taken twice daily for a total of 14 days.

Dietary Supplement: Omega-3

Interventions

Omega-3 DIETARY_SUPPLEMENT

200ml, pre-mixed oral nutritional supplement supplying 1.42g per bottle of EPA and DHA.

Omega-3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with colorectal cancer undergoing elective laparoscopic colorectal resection.
• Adult aged 18 or over.
• Capacity to consent

You may not qualify if:

• Pre-existing diagnosis of Diabetes mellitus, requiring medication.
• Consumption of \> 3 alcoholic drinks/day
• Already on omega-3 supplementation
• Pregnant
• Patients on heparin infusion perioperatively
• Patients on immunosuppressive drugs
• Regular / Daily smokers
• Patients requiring a blood transfusion at any point day 7 pre-op to day 1 post operatively.
• Vegan or Vegetarian
• Allergy to cows milk or wheat

Sponsors & Collaborators

• Royal Surrey County Hospital NHS Foundation Trust: lead

Study Sites (1)

Royal Surrey County Hospital

Guildford, Surrey, GU2 7WG, United Kingdom

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Malnutrition; Wound Infection; Surgical Wound Infection; Postoperative Complications; Sarcopenia; Phagocyte Bactericidal Dysfunction

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single blind trial, analysis of all samples blinded to investigation team.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgical Research Fellow

Model Details: Prospective Randomised controlled trial

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: July 26, 2018
• Study Start: July 16, 2018
• Primary Completion: September 19, 2019
• Study Completion: September 19, 2019
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)