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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03598413
Other study ID # 18SURN238410
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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