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PeRioperative Omega Three and the Effect on ImmuNity (PROTEIN)

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ClinicalTrials.gov Identifier: NCT03598413
Recruitment Status : Unknown
Verified August 2018 by Daniel White, Royal Surrey County Hospital NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : July 26, 2018
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Daniel White, Royal Surrey County Hospital NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Nutritional Deficiency Infected Wound Surgical Site Infection Complication, Postoperative Surgery Surgery--Complications Sarcopenia Phagocytic Dysfunction Dietary Supplement: Omega-3 Not Applicable

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 50 patients, 25 to receive the supplement, and 25 to form a comparison or control group.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective Randomised controlled trial
Masking: Single (Investigator)
Masking Description: Single blind trial, analysis of all samples blinded to investigation team.
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Standard or DHA/EPA Supplemented Enteral Nutrition in Patients Undergoing Laparoscopic Colorectal Surgery
Actual Study Start Date : July 16, 2018
Estimated Primary Completion Date : October 5, 2019
Estimated Study Completion Date : December 5, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Patients undergoing standard laparoscopic colorectal resection with no omega-3 enriched peri-operative nutritional support
Experimental: Omega-3
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.
Dietary Supplement: Omega-3
200ml, pre-mixed oral nutritional supplement supplying 1.42g per bottle of EPA and DHA.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03598413


Contacts
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Contact: Daniel White, MBBS 01483688691 daniel.white123@nhs.net

Locations
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United Kingdom
Royal Surrey County Hospital Recruiting
Guildford, Surrey, United Kingdom, GU2 7WG
Contact: Daniel White, MBBS    01483688691    daniel.white123@nhs.net   
Sponsors and Collaborators
Royal Surrey County Hospital NHS Foundation Trust
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Responsible Party: Daniel White, Surgical Research Fellow, Royal Surrey County Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03598413    
Other Study ID Numbers: 18SURN238410
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Ethical approval allows for sharing of anonymised data with collaborators at the University of Surrey.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daniel White, Royal Surrey County Hospital NHS Foundation Trust:
enhanced recovery
perioperative nutrition
macrophages
omega 3 fatty acids
Additional relevant MeSH terms:
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Surgical Wound Infection
Sarcopenia
Phagocyte Bactericidal Dysfunction
Malnutrition
Postoperative Complications
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Wound Infection
Infection
Pathologic Processes
Nutrition Disorders
Leukocyte Disorders
Hematologic Diseases
Immunologic Deficiency Syndromes
Immune System Diseases