A study of a new tool to help doctors decide whether radiotherapy will work for bone pain (TiBoP)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

All cancer types

Cancer spread to the bone

Secondary cancers

Status:

Closed

Phase:

Other

This study is for people who have bone pain caused by cancer. Everyone taking part is going to have radiotherapy to the bone in 1 of the following hospitals:

the Western general hospital in Edinburgh
the Ninewells hospital in Dundee

More about this trial

Cancer that spreads from where it started to the bone (secondary bone cancer) can cause pain.

You might have an area in the bone that is painful or tender. Bone pain can be severe and it might be painful even when you are resting.

Radiotherapy uses high energy waves similar to x-rays to kill cancer cells. It can slow down the cancer and help with the bone pain.

But radiotherapy for bone pain doesn’t always work. Some people continue to have pain, or have more pain, after treatment.

Doctors would like to know who benefits from having radiotherapy for bone pain. In this study, they are using a test that looks at how you feel warm and cool on your skin over where your pain is. They think this will help to tell who benefits from radiotherapy.

The main aim of this study is to see if the new tool can tell who benefits from radiotherapy for bone pain. Doctors hope to use the results of this study to do a bigger trial.

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

Who can take part
You may be able to join this study if all of the following apply. You:

have bone pain caused by the cancer
rate your pain as more than 4 out of 10 (where 0 means no pain at all and 10 means the worst pain you can imagine)
are going to have radiotherapy for bone pain
are aged between 18 and 100 years old

Who can’t take part
You cannot join this study if any of these apply:

you are staying or living in a hospital (inpatient)
you are confused or have serious problems with your mental health
your doctor thinks that you might become unwell very rapidly
you have any other medical condition that your doctor thinks may affect you taking part in this study

Trial design

Researchers hope that around 144 people will take part in this study. Everyone is going to have radiotherapy for bone pain in either:

the Western general hospital in Edinburgh
the Ninewells hospital in Dundee

Taking part in this study does not affect the radiotherapy treatment you have. This is the same as if you weren’t in this study.

You usually have 1 radiotherapy session. Your doctor will explain your treatment and what to expect.

You meet the study team before the start of radiotherapy. They ask you to complete some questionnaires. It asks about your pain and how it affects you. The questionnaires take about 15 to 20 minutes to complete.

The study team tests how you feel warm and cool on the skin over the painful bone. To do this, they place a small probe lightly on your skin. They then ask you if you if it feels warm or cold. The test takes up to 5 minutes. They also test an area where you don’t have pain as a comparison.

TiBoP Diagram

Blood and urine tests
The study team may ask you to give:

a blood sample before and 6 weeks after the end of radiotherapy
a urine sample before and at set times after the end of radiotherapy (up to 4 samples in total)

The team might keep the samples and use them in future research studies. You don’t have to agree to the extra blood and urine tests if you don’t want to. You can still take part in this trial.

Hospital visits

You meet the study team before the start of radiotherapy and in a place that suits you best. It can be at your home or at the hospital.

You go to Western general hospital or Ninewells hospital to have the radiotherapy treatment.

After treatment, you speak with the study team after a week. This is to see how you are and whether you have any side effects from radiotherapy.

You then see or speak with the study team after:

2 weeks
6 weeks
12 weeks (3 months)

On each visit, you complete some questionnaires and have the same test to see whether it feels warm or cold when they place the probe on your skin. You can have the test in a place that suits you best, such as at your home.

Side effects

The trial team doesn’t think you will have any side effects from taking part in this study. But you might have side effects from the radiotherapy to the bone.

Your doctor will tell you about all the possible side effects of radiotherapy before taking part. We have information about the side effects of radiotherapy for bone pain.