Colorectal CancerPROTEINNCT03598413
PeRioperative Omega Three and the Effect on ImmuNity
A study testing Omega-3 in people with Colorectal Cancer and Nutritional Deficiency, run by Royal Surrey County Hospital NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Nutritional Deficiency, Infected Wound
- What is being tested?
- Omega-3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Jul 2018to 19 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with colorectal cancer undergoing elective laparoscopic colorectal resection.
- Adult aged 18 or over.
- Capacity to consent
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Surrey County Hospital
Guildford, Surrey, GU2 7WG
About this study
Official title: A Randomized Controlled Trial of Standard or DHA/EPA Supplemented Enteral Nutrition in Patients Undergoing Laparoscopic Colorectal Surgery
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.
Read the 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.
- Conditions
- Colorectal Cancer, Nutritional Deficiency, Infected Wound, Surgical Site Infection, Complication, Postoperative, Surgery
- Being tested
- Omega-3
- Keywords
- enhanced recovery, perioperative nutrition, macrophages, omega 3 fatty acids
- Medical subject headings
- Colorectal Neoplasms, Malnutrition, Wound Infection, Surgical Wound Infection, Postoperative Complications, Sarcopenia, Phagocyte Bactericidal Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3Dietary supplement
200ml, pre-mixed oral nutritional supplement supplying 1.42g per bottle of EPA and DHA.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients undergoing standard laparoscopic colorectal resection with no omega-3 enriched peri-operative nutritional support |
| Omega-3 | Experimental | 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. Receives: Dietary Supplement: Omega-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Phagocytosis of pathogens
Phagocytosis of E.Coli, S.Aureus and Candida measured with flow cytometry
Measured: Baseline [2-4 weeks before surgery], Day of Surgery [day 7 post nutritional supplementation], Day 1 post surgery [day 8 post supplementation].
Changes in cell membrane composition
Using gas chromatography, measuring the percentage of omega-3 within cell membranes
Measured: Baseline [2-4 weeks before surgery], Day of Surgery [day 7 post nutritional supplementation], Day 1 post surgery [day 8 post supplementation].
Secondary outcomes (6)
Infectious complications
Descriptions laid out in supplement 1 for diagnostic criteria
Measured: 30 days
Non-infectious complications
Descriptions laid out in supplement 1 for diagnostic criteria
Measured: 30 days
Length of hospital stay
Length of stay in days as per electronic discharge records
Measured: A maximum of 90 days
Sarcopenia
Changes in body composition measured on CT scan
Measured: Baseline [Pre-operative staging CT scan] and 6 month +/-2 months
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.
Measured: Baseline and 3 weeks post surgery +/- 7 days
Changes in Hand grip strength
Physical measurement of hand grip strength using hand dyanamometer to assist in diagnosis of sarcopenia / functional status.
Measured: Baseline [Pre-operative staging CT scan] and 6 month +/-2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start16 Jul 2018
- Primary completion19 Sep 2019
- Study completion19 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Prospective Randomised controlled trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel White, Royal Surrey County Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598413
- Sponsor's protocol ID
- 18SURN238410
- Acronym
- PROTEIN
- Status last verified
- Sep 2022
- First submitted
- 3 Jul 2018
- Last updated
- 28 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ethical approval allows for sharing of anonymised data with collaborators at the University of Surrey.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Standard or DHA/EPA Supplemented Enteral Nutrition in Patients Undergoing Laparoscopic Colorectal Surgery
- ClinicalTrials.gov ID
- NCT03598413
- Acronym / sponsor ID
- PROTEIN / 18SURN238410
- Conditions
- Colorectal Cancer, Nutritional Deficiency, Infected Wound, Surgical Site Infection, Complication, Postoperative, Surgery
- Keywords
- enhanced recovery, perioperative nutrition, macrophages, omega 3 fatty acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 19 Sep 2019 (actual)
- Study completion
- 19 Sep 2019 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Prospective Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients undergoing standard laparoscopic colorectal resection with no omega-3 enriched peri-operative nutritional support |
| Omega-3 | Experimental | Dietary Supplement: Omega-3Patients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with colorectal cancer undergoing elective laparoscopic colorectal resection.
- Adult aged 18 or over.
- Capacity to consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3200ml, pre-mixed oral nutritional supplement supplying 1.42g per bottle of EPA and DHA. | Dietary supplement | Omega-3 |
Primary outcome
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
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
6 secondary outcomes
Infectious complications
Time frame: 30 days
Non-infectious complications
Time frame: 30 days
Length of hospital stay
Time frame: A maximum of 90 days
Sarcopenia
Time frame: Baseline [Pre-operative staging CT scan] and 6 month +/-2 months
Quality of Life (EORTC: QLQC30)
Time frame: Baseline and 3 weeks post surgery +/- 7 days
Changes in Hand grip strength
Time frame: Baseline [Pre-operative staging CT scan] and 6 month +/-2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: No. Ethical approval allows for sharing of anonymised data with collaborators at the University of Surrey.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 in people with Colorectal Cancer and Nutritional Deficiency, run by Royal Surrey County Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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].). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.