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PeRioperative Omega Three and the Effect on ImmuNity (PROTEIN)

Primary Purpose

Colorectal Cancer, Nutritional Deficiency, Infected Wound

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Omega-3
Sponsored by
Royal Surrey County Hospital NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring enhanced recovery, perioperative nutrition, macrophages, omega 3 fatty acids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Royal Surrey County Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Omega-3

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Changes in Phagocytosis of pathogens
Phagocytosis of E.Coli, S.Aureus and Candida measured with flow cytometry
Changes in cell membrane composition
Using gas chromatography, measuring the percentage of omega-3 within cell membranes

Secondary Outcome Measures

Infectious complications
Descriptions laid out in supplement 1 for diagnostic criteria
Non-infectious complications
Descriptions laid out in supplement 1 for diagnostic criteria
Length of hospital stay
Length of stay in days as per electronic discharge records
Sarcopenia
Changes in body composition measured on CT scan
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.
Changes in Hand grip strength
Physical measurement of hand grip strength using hand dyanamometer to assist in diagnosis of sarcopenia / functional status.

Full Information

First Posted
July 3, 2018
Last Updated
September 26, 2022
Sponsor
Royal Surrey County Hospital NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03598413
Brief Title
PeRioperative Omega Three and the Effect on ImmuNity
Acronym
PROTEIN
Official Title
A Randomized Controlled Trial of Standard or DHA/EPA Supplemented Enteral Nutrition in Patients Undergoing Laparoscopic Colorectal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 16, 2018 (Actual)
Primary Completion Date
September 19, 2019 (Actual)
Study Completion Date
September 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Royal Surrey County Hospital NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective Randomised controlled trial
Masking
Investigator
Masking Description
Single blind trial, analysis of all samples blinded to investigation team.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients undergoing standard laparoscopic colorectal resection with no omega-3 enriched peri-operative nutritional support
Arm Title
Omega-3
Arm Type
Experimental
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3
Intervention Description
200ml, pre-mixed oral nutritional supplement supplying 1.42g per bottle of EPA and DHA.
Primary Outcome Measure Information:
Title
Changes in Phagocytosis of pathogens
Description
Phagocytosis of E.Coli, S.Aureus and Candida measured with flow cytometry
Time Frame
Baseline [2-4 weeks before surgery], Day of Surgery [day 7 post nutritional supplementation], Day 1 post surgery [day 8 post supplementation].
Title
Changes in cell membrane composition
Description
Using gas chromatography, measuring the percentage of omega-3 within cell membranes
Time Frame
Baseline [2-4 weeks before surgery], Day of Surgery [day 7 post nutritional supplementation], Day 1 post surgery [day 8 post supplementation].
Secondary Outcome Measure Information:
Title
Infectious complications
Description
Descriptions laid out in supplement 1 for diagnostic criteria
Time Frame
30 days
Title
Non-infectious complications
Description
Descriptions laid out in supplement 1 for diagnostic criteria
Time Frame
30 days
Title
Length of hospital stay
Description
Length of stay in days as per electronic discharge records
Time Frame
A maximum of 90 days
Title
Sarcopenia
Description
Changes in body composition measured on CT scan
Time Frame
Baseline [Pre-operative staging CT scan] and 6 month +/-2 months
Title
Quality of Life (EORTC: QLQC30)
Description
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.
Time Frame
Baseline and 3 weeks post surgery +/- 7 days
Title
Changes in Hand grip strength
Description
Physical measurement of hand grip strength using hand dyanamometer to assist in diagnosis of sarcopenia / functional status.
Time Frame
Baseline [Pre-operative staging CT scan] and 6 month +/-2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Royal Surrey County Hospital
City
Guildford
State/Province
Surrey
ZIP/Postal Code
GU2 7WG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Ethical approval allows for sharing of anonymised data with collaborators at the University of Surrey.

Learn more about this trial

PeRioperative Omega Three and the Effect on ImmuNity

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