A study to improve treatment for side effects of radiotherapy to the bowel (The ORBIT study)

Please note this trial is no longer recruiting patients.

This study is to see which tests and treatments can help people cope with bowel problems caused by radiotherapy, and who is best to give these.

If you have radiotherapy anywhere in the area between your hips (your ‘pelvis’), this is called ‘pelvic’ radiotherapy. This includes radiotherapy to treat cancer of your prostate, womb or cervix. But a large part of your bowel is also inside this area. So if you have pelvic radiotherapy, some of your healthy bowel tissue may be affected by the radiation.

These pelvic radiotherapy side effects can be long term and include diarrhoea, leaking of your bowel motion (stool), pain or bleeding from your back passage. Because people can be embarrassed by these problems, they don’t always tell their doctors and nurses. Even if they do, it can be difficult to get practical help and support from experts, as there are relatively few for this particular area. Researchers believe that certain tests and treatments may help these bowel problems. But they need to prove this. They also want to develop a network of specialist nurses to provide support, and arrange these possible tests and treatments. The aims of this study are to

Find out which tests can find the cause of people’s bowel symptoms, and if certain treatments can improve quality of life
Develop a series of steps (an 'algorithm') to guide health professionals in choosing the most suitable tests and treatments for each person, and see how well this works
See if a specialist nurse using these steps can give care to the same level as a stomach specialist (gastroenterologist)
Find out what other healthcare needs people with bowel symptoms after radiotherapy have
Learn more about costs surrounding this illness, both to the patient and the NHS

Recruitment

Start 01/10/2007

End 18/12/2011

Phase

Other

Who can enter

You may be able to enter this study if you

Are being treated at the Royal Marsden Hospital
Have had radiotherapy intended to cure prostate cancer, bladder cancer, cancer of the vulva, vagina, cervix or womb (endometrium), cancer of the anus or rectum, or cancer affecting the lymph glands that run up the body’s major blood vessel (the aorta)
Are having new problems with your stomach or bowel at least 6 months after completing your pelvic radiotherapy
Are able to travel to the Royal Marsden Hospital in Chelsea for outpatient appointments

You cannot enter this study if

Your doctor is already sending you to a stomach specialist (gastroenterologist) for your symptoms
You have an opening to the outside of your body (stoma) from your bowel, formed during surgery (an ileostomy or colostomy) - if your surgeon plans to reverse your stoma, you can take part after that
You have any other condition apart from your cancer that could affect you taking part or the results of the study - you can check this with your doctor
You have been to a clinic run by any of the doctors or nurses taking part in this study

Trial design

This study will recruit 218 people. This is a randomised study. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

Everyone will be asked to fill out some questionnaires before the study, and then every 6 months for a year after they join the study. The questionnaires will ask you about any side effects you have had and about how you have been feeling. These are called quality of life studies. You will also fill out some much shorter questionnaires at your first follow up appointment.

There are 3 groups in this study. The people in group 1 are given advice on how to manage their bowel symptoms themselves, and asked to see the study team 6 months later to discuss how well this worked.

If you are in group 2, you see a stomach specialist and have some tests. The tests you have will depend on your symptoms, and may include

Blood tests
Looking at the inside of your digestive system (endoscopy)
Taking pictures of your digestive system using scans or X- rays

You will then have treatment based on these test results. The treatment will aim to help the actual cause of the side effects.

If you are in group 3, you see a specialist nurse. You will have tests and treatment in the same way as people in group 2.

Hospital visits

Everyone will see the research team at the start of the study and will receive questionnaires at 6 months and 12 months at home. If you are in group 3, you will be seen by the nurse. But if your symptoms carry on, you will be moved to group 2, and see the specialist doctor.

You will visit the hospital for any tests you may need, and to see the specialist doctor or nurse to discuss these test results. The treatment you have as a result may or may not involve further hospital visits.