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Completed

NCT Number: NCT03598413

PeRioperative Omega Three and the Effect on ImmuNity

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3

Dietary Supplement

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

Primary outcomes

  1. Changes in Phagocytosis of pathogens

    Time frame: Baseline [2-4 weeks before surgery], Day of Surgery [day 7 post nutritional supplementation], Day 1 post surgery [day 8 post supplementation].

    Phagocytosis of E.Coli, S.Aureus and Candida measured with flow cytometry

  2. Changes in cell membrane composition

    Time frame: Baseline [2-4 weeks before surgery], Day of Surgery [day 7 post nutritional supplementation], Day 1 post surgery [day 8 post supplementation].

    Using gas chromatography, measuring the percentage of omega-3 within cell membranes

Secondary outcomes

  1. Infectious complications

    Time frame: 30 days

    Descriptions laid out in supplement 1 for diagnostic criteria

  2. Non-infectious complications

    Time frame: 30 days

    Descriptions laid out in supplement 1 for diagnostic criteria

  3. Length of hospital stay

    Time frame: A maximum of 90 days

    Length of stay in days as per electronic discharge records

  4. Sarcopenia

    Time frame: Baseline [Pre-operative staging CT scan] and 6 month +/-2 months

    Changes in body composition measured on CT scan

  5. Quality of Life (EORTC: QLQC30)

    Time frame: Baseline and 3 weeks post surgery +/- 7 days

    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.

  6. Changes in Hand grip strength

    Time frame: Baseline [Pre-operative staging CT scan] and 6 month +/-2 months

    Physical measurement of hand grip strength using hand dyanamometer to assist in diagnosis of sarcopenia / functional status.

Sponsors and collaborators

Lead sponsor

Royal Surrey County Hospital NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: PROTEIN

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 26, 2018
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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