A trial looking at food supplement drinks in people with bowel cancer related weight loss (POSiCC)

This trial is looking at diet advice with or without food supplement drinks before surgery for bowel cancer. The aim is to see if the drinks help people recover.

We know from research that people who have cancers affecting their bowel often lose weight as a result of their illness. This can sometimes lead to problems because the body is weaker and finds it harder to cope with cancer treatment.

People can gain weight by having liquid food through a tube into their stomach, or through a drip into a vein. People fed in these ways have fewer complications after surgery, stay in hospital for a shorter time and have a better outcome after treatment. But giving food like this is expensive and means that you need to have a drip, or a tube put into your stomach. You may need to stay in hospital for a while before surgery, or have equipment and supplies delivered to your home.

So researchers in this trial want to see if standard food supplement drinks can help people with this cancer related weight loss, and if people are happy to take them. Half the people taking part will have standard advice on how to improve their diet, and the other half will also have food supplement drinks. The aim of this trial is to see if people who have these food supplement drinks before bowel cancer surgery as well as diet advice have fewer complications than people who just have the standard diet advice.

Recruitment

Start 08/05/2012

End 01/04/2013

Phase

Other

You may be able to enter this trial if you

Are being cared for by doctors or surgeons at the Central Manchester Foundation Trust
Have cancer that started in the bowel
Are able to have surgery aimed at curing your cancer
Have lost more than 1kg in weight (about 2¼ lbs) in the last 6 months

You cannot enter this trial if you

Have diabetes
Are already taking a supplement to help you put on weight
Have a pacemaker or any other metal device in your body
Are taking part in another clinical trial
Are pregnant

This trial will recruit 126 people. It is randomised. The people taking part are put into one of 2 groups randomly.

If you are in group 1, a trained dietician will talk to you about how to increase energy and protein in your diet.

If you are in group 2, as well as this advice, you will have a course of food supplements to take.

Whichever group you are in, the dietician will monitor you throughout the trial. They will measure

Your height and weight
How strongly you can grip something
Folds of skin, and around your upper arm
The amount of muscle and fat in your body – you will need to lie down for this

You will fill out 3 questionnaires, and tell the dietician what you ate the day before. The dietician may also ask if you would be willing to be interviewed. The interview will ask how you found increasing your protein and energy. If you agree, the dietician will tape record this interview.

You repeat these tests and 2 of the questionnaires before and after surgery. The dietician will contact you again 3 months after your surgery to ask how you are, and send you 2 more questionnaires. You return these in a pre paid envelope.

The research team will monitor any complications people taking part may have after their surgery.

The dietician will visit you at home for the first session, which will take about 40 minutes. If you are having a tape recorded interview, you will have it at this visit.

You then see the dietician at the hospital, a couple of days before your surgery, and again while you are in hospital, about a week after your surgery. These sessions will last about 30 minutes.

The last assessments will be done over the phone and by post.

Side effects of the supplements may include

Feeling sick
Diarrhoea
Feeling quite heavy or full (bloated)

If you feel any of these side effects the trial team may advise you to stop taking the supplements, to calm these effects down.

Following the diet advice may make you feel full up! This is normal as the advice is designed to increase your energy and protein intake.

Location of trial

For more information

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Find out how to join a trial or contact our cancer information nurses for other questions about cancer by phone (0808 800 4040), by email, or at

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