PeRioperative Omega Three and the Effect on ImmuNity

NCT ID: NCT03598413

Last Updated: 2022-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-16
• Study Completion Date: 2019-09-19

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.

Detailed Description

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. We are increasingly familiar with the term BMI, body mass index, which we use to categorise obesity in healthcare. A newer term in this realm is that of sarcopenia, a low muscle mass relative to your size, unrelated to your weight or fat density. This can be measured in a number of ways, including on a scan performed routinely in bowel cancer care, a CT scan. Evidence shows that people with low muscle mass, irrespective of their overall weight, experience more complications than those who have healthier amounts of muscle. We hypothesise that patients supplemented with fish oils both before and after surgery will experience an enhancement of their immune response, and subsequently encounter fewer infectious complications, a shorter length of hospital stay and improved quality of life. We also predict fewer patients having extra nutrition before and after surgery will develop sarcopenia and avoid the risks associated with that condition. The trial will only take place in those with bowel cancer who are planned to have a keyhole operation, as this is now the most commonplace approach to surgery. We plan to recruit 40 patients, 20 to receive the supplement, and 20 to form a comparison or control group.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Omega-3

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.

Group Type: EXPERIMENTAL

Omega-3

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Omega-3

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Surrey County Hospital NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Daniel White

Surgical Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Royal Surrey County Hospital

Guildford, Surrey, United Kingdom

Countries

United Kingdom

Other Identifiers

18SURN238410

Identifier Type: -

Identifier Source: org_study_id