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PeRioperative Omega Three and the Effect on ImmuNity (PROTEIN)

R

Royal Surrey County Hospital NHS Foundation Trust

Status

Completed

Conditions

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

Treatments

Dietary Supplement: Omega-3

Study type

Interventional

Funder types

Other

Identifiers

NCT03598413
18SURN238410

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

40 participants in 2 patient groups

Control
No Intervention group
Description:
Patients undergoing standard laparoscopic colorectal resection with no omega-3 enriched peri-operative nutritional support
Omega-3
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Omega-3

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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