PeRioperative Omega Three and the Effect on ImmuNity

Colorectal Cancer Clinical Trial

— PROTEIN  

Official title:

A Randomized Controlled Trial of Standard or DHA/EPA Supplemented Enteral Nutrition in Patients Undergoing Laparoscopic Colorectal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03598413
• Other study ID #: 18SURN238410
• Status: Completed
• Phase: N/A
• Start date: July 16, 2018
• Est. completion date: September 19, 2019

Study information

• Verified date: September 2022
• Source: Royal Surrey County Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 19, 2019
• Est. primary completion date: September 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Omega-3
200ml, pre-mixed oral nutritional supplement supplying 1.42g per bottle of EPA and DHA.

Locations

Country	Name	City	State
United Kingdom	Royal Surrey County Hospital	Guildford	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Royal Surrey County Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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].
Primary	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	Infectious complications	Descriptions laid out in supplement 1 for diagnostic criteria	30 days
Secondary	Non-infectious complications	Descriptions laid out in supplement 1 for diagnostic criteria	30 days
Secondary	Length of hospital stay	Length of stay in days as per electronic discharge records	A maximum of 90 days
Secondary	Sarcopenia	Changes in body composition measured on CT scan	Baseline [Pre-operative staging CT scan] and 6 month +/-2 months
Secondary	Quality of Life (EORTC: QLQC30)	Quality of life questionnaire EORTC: QLQC30. A 30 element validated questionnaire. Symptoms are grouped into scales: Physical Function, Role Function, Emotional Function, Cognitive Function, and Social Function. In addition symptom scales including: Fatigue, Nausea, vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties. 28 of the scales range from 1 to 4, 4 being most symptomatic, 1 least so. The 2 remaining scales for overall health and quality of life are scaled 1-7, with 7 being the best and 1 the worst. The 30 questions can be combined for a global score, in which instance the 2 global scales are reversed so that 7 becomes the worst quality of life or health and 1 the best.	Baseline and 3 weeks post surgery +/- 7 days
Secondary	Changes in Hand grip strength	Physical measurement of hand grip strength using hand dyanamometer to assist in diagnosis of sarcopenia / functional status.	Baseline [Pre-operative staging CT scan] and 6 month +/-2 months