“I think it’s essential that people keep signing up to these type of trials to push research forward.”
A study looking at lifestyle changes in people with pre cancerous bowel growths
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at changing diet and exercise levels in people who have had pre cancerous growths called adenomas removed from their bowel.
One of the aims of the NHS Bowel Cancer Screening Programme is to spot early stage colorectal cancer. The programme also looks for a type of pre cancerous tissue growth called adenoma. If you have a colonoscopy and the doctor finds an adenoma, they will remove it during this procedure and this will stop it from going on to develop into a cancer. But adenomas can come back.
This study is in 2 parts. The aim of the whole study is to see if people will cut down on red meat, stop eating processed meat and increase their levels of exercise with the aim of lowering their bowel cancer risk. This is because a report by The World Cancer Research Fund in 2007 found there was strong evidence that a diet high in red and processed meat, and low levels of physical activity cause bowel cancer.
The first part of this study found out which were the best ways to bring about a change in people’s lifestyles. Part 2 of this study is a trial with people who have had high risk adenomas removed. Some will be asked to make changes to their lifestyle. Researchers will look at change in behaviour, how well people taking part stick to their new lifestyle plan, and at how acceptable people find these interventions. If successful, a future trial would aim to prove that these behaviour changes can reduce the chance of high risk adenomas coming back.
Who can enter
You may be able to enter if
- You are under the care of the Royal Wolverhampton Hospitals NHS Trust or Shrewsbury and Telford Hospitals NHS Trust
- You have been diagnosed with a growth in your bowel called an adenoma in the last year that doctors think is high or medium (intermediate) risk of becoming cancer
- Your adenomas are of a suitable size and number for this study – you can check this with your doctor
- You were between 60 and 74 years of age when you were diagnosed
You cannot enter if you are
- Continuing to be monitored for bowel cancer because you are high risk for any reason
- Not able to exercise
- Having treatment for cancer
- Vegetarian, and have been for more than 3 months
- Very physically active (you exercise 3 times more than the current guidelines of 30 minutes of moderate exercise 5 times per week)
This is a pilot study of a phase 2 trial. This study is randomised. Before March 2012, the people taking part were put into one of 4 groups by a computer. Groups 1, 2 and 3 were looking at different lifestyle changes. People in group 4 did not change anything. But if you take part from April 2012, the computer will only decide whether you will follow a lifestyle change, or not change anything. If the computer decides you will follow a lifestyle change, you can then choose which lifestyle change group to join.
If you are in group 1 you will be asked to eat less red meat, and cut out processed meat from your diet. The team describe processed meat as meat (usually red meat) that has been preserved by processes called smoking, curing or salting or by adding other chemical preservatives. Processed meat includes ham, bacon, sausages, salami, corned beef and pepperoni.
If you are in group 2 you will be asked to increase your exercise levels to the national recommended weekly amount – the team will explain more about this when you join the study.
If you are in group 3, you will do both of these.
If you are in group 4 you will not change anything – you are the ‘control’ group.
Before the trial starts, the team will ask you about your current diet and exercise levels. Everyone will then fill out some questionnaires during the study - the team will tell you more about this.
If you are in a group changing your exercise levels, you will be guided by the Healthy Lifestyles Service or Health Trainers. They will give you advice and encouragement about exercise, and you will have between 2 and 8 sessions.
If you are in a group changing your diet, you will be guided by an experienced dietician at the hospital or a Health Trainer, depending on where you live.
If you are in the group making both changes, you will be guided by the Healthy Lifestyles Service or the Health Trainers.
If you are in the group not making any changes, the team will give you some general advice about healthy living.
Everyone will see the trial team at the beginning and end of the trial.
If you are being guided by the Healthy Lifestyles Service or the Health Trainers you will have up to 8 sessions. Each session will last up to an hour. These could be either at their offices, at a sports centre, at home or by phone. You will be able to discuss with the team the most convenient place for you.
If you are in group 1 (changing just your diet) and being guided by a dietician, you will meet once with the dietician at New Cross Hospital, and then keep in touch each month by phone.
The trial team do not expect that you will have any side effects from the diet or exercise programmes. Any changes you will be making during the trial will be introduced in stages.
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.
Professor Sue Wilson
NIHR Research for Patient Benefit (RfPB) Programme
NIHR Clinical Research Network: Cancer
University of Birmingham