Clinical trial NCT03598413: PeRioperative Omega Three and the Effect on ImmuNity
Official title: A Randomized Controlled Trial of Standard or DHA/EPA Supplemented Enteral Nutrition in Patients Undergoing Laparoscopic Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Royal Surrey County Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Prospective Randomised controlled trial
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Changes in Phagocytosis of pathogens
timeFrame: Baseline [2-4 weeks before surgery], Day of Surgery [day 7 post nutritional supplementation], Day 1 post surgery [day 8 post supplementation].
measure: Changes in cell membrane composition
timeFrame: Baseline [2-4 weeks before surgery], Day of Surgery [day 7 post nutritional supplementation], Day 1 post surgery [day 8 post supplementation].
Secondary outcomes:
measure: Infectious complications
timeFrame: 30 days
measure: Non-infectious complications
timeFrame: 30 days
measure: Length of hospital stay
timeFrame: A maximum of 90 days
measure: Sarcopenia
timeFrame: Baseline [Pre-operative staging CT scan] and 6 month +/-2 months
measure: Quality of Life (EORTC: QLQC30)
timeFrame: Baseline and 3 weeks post surgery +/- 7 days
measure: Changes in Hand grip strength
timeFrame: Baseline [Pre-operative staging CT scan] and 6 month +/-2 months
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
state: Surrey
Study officials:
References: