A study looking at a fish oil supplement in people having surgery aimed at curing bowel cancer (EPA colo)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This study is looking at a fish oil supplement called eicosapentaenoic acid or EPA. This may improve recovery after surgery aiming to cure bowel cancer.
If you have surgery to treat bowel cancer, you may have some muscle wasting which may affect how quickly you recover from surgery. EPA is an found in fish oil and oily fish, or as supplements such as cod liver oil. Researchers believe that EPA may improve recovery after surgery for bowel cancer by preserving muscle that often wastes away after major surgery or due to cancer.
In this study, they will give half the people taking part an EPA supplement before surgery and for 3 weeks afterwards. The other half will take dummy capsules ().
The main aim of this study is to see if taking EPA can help improve both the amount of muscle and how well it works in people having surgery aiming to cure cancer of the bowel.
Who can enter
You may be able to enter this study if you
- Have bowel cancer
- Are due to have surgery aimed at curing your cancer
- Are between 18 and 85 years old
You cannot enter this study if
- You are having chemotherapy to shrink the cancer before surgery
- You are having keyhole procedures to your bowel
- Your cancer has spread to another part of your body
- You will be doing a lot of exercise 48 hours before your pre surgery appointment
- You need to have injections into your muscle within 48 hours of going to your study visits
- You have numbness or tingling in your hands or feet (peripheral neuropathy), or any muscle disease (myopathy)
- You have any problems moving around
- You have any physical injury as a result of an accident
- You are already taking a fish oil supplement
- You have difficulty eating or drinking for any reason
- You have a heart or lung condition that would mean you are not able to have surgery
- You are pregnant
Trial design
This study will recruit 70 people. It is randomised. The people taking part are put into one of 2 groups randomly. Neither you nor your doctor will be able to decide or know which group you are in. This is called a double blind study.
One group take EPA capsules and the other take dummy capsules (placebos). You take 2 capsules, 3 times a day, from 5 days before your surgery until 21 days after surgery. The surgery itself is not part of the study.
Before and after your surgery you
- Have an exercise bike test
- Have a
bone density (DEXA) scan of your whole body
- Have your grip measured by squeezing a trigger device
- Fill out some quality of life questionnaires
You also give some blood samples, and 2 small samples of muscle, about the size of an orange pip (muscle biopsies). You have your biopsies taken under .
Hospital visits
You have the first exercise test, DEXA scan and grip test on the same day as your routine pre surgery appointment. These tests will take about 45 minutes.
You give your muscle biopsies during your surgery, and at your routine follow up appointment after your surgery.
The only extra visit you make to take part in this study is 4 weeks after your surgery, where you repeat the pre surgery study tests to check your fitness.
Side effects
The exercise bike test will not make people exercise harder than they are able. But a doctor will monitor your heart rate, and stop the test if they think there is any strain on your heart.
You will be exposed to a small amount of radiation from the DEXA scan, but only the same amount as you would get from sitting outside for a day.
Possible side effects of biopsies include
- A collection of blood under the skin (haematoma)
- Bruising, infection and pain
Possible side effects of EPA include
- Softer stools or opening your bowels more often
- Taste changes
- Dizziness
- Short term changes to the way your liver works
- Headache
- Raised blood sugar levels
- Skin spots and blemishes (acne)
- Rash
- Low blood pressure
- Dryness inside your nose
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Dr John Williams
Supported by
University of Nottingham
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040