A trial looking at pregabalin and radiotherapy for pain caused by secondary cancer in the bones

Cancer type:

All cancer types

Status:

Results

Phase:

Phase 4

This trial looked at a drug called pregabalin to see if it can help to reduce pain caused by secondary cancer in the bones. People taking part in this trial also had radiotherapy to relieve their pain. This trial was supported by Cancer Research UK.

More about this trial

Secondary cancer Open a glossary item in the bones can cause pain that is sometimes difficult to treat. Doctors may use both painkillers and radiotherapy for bone pain.

In this trial, the researchers looked at a drug called pregabalin. This is already a treatment for nerve pain, but they thought it might also help to relieve bone pain.

The aim of the trial was to find out if taking pregabalin after radiotherapy works better than having radiotherapy alone for bone pain.

Summary of results

The trial team found that taking pregabalin did not help people who had bone pain caused by cancer.

The trial was in 2 parts. First people had their pain assessed by a doctor or a nurse.

If their pain measured 4 or more on a scale of 0 to10 they took part in the treatment part of the trial.

The trial was randomised. This means people were put into one of 2 treatment groups by a computer. The treatment looked the same for both groups. This is called a double blind trial.

233 people took part. Everybody had radiotherapy, and then

116 people had pregabalin tablets twice a day for 4 weeks
117 people had dummy tablets (placebos ) twice a day for 4 weeks

trial diagram

The researcher’s main aims were

For people’s worst pain to reduce by 2 points on the pain scale after the treatment
For people to be on the same dose (or less) of their painkillers after the treatment

They found that this happened for

45 people in the pregabalin group
47 people in the dummy drug group

The researchers also looked at

How often people were in pain
How much pain interfered with people’s daily life and activity
If people had sudden pain despite having painkillers (breakthrough pain)
People’s mood during treatment
Any side effects from treatment

The researchers found no difference between the 2 groups for

How often people were in pain
How much pain interfered with daily life and activity.

The people taking pregabalin said their mood improved and they had less breakthrough pain. But the researchers pointed out that numbers of people who reported this was still not high enough for them to be confident in this finding. They also pointed out that pregabalin is a treatment for anxiety.

People in both groups had side effects.

27 people in the pregabalin group
24 people in the dummy drug group

The most common side effects included

Feeling and being sick
Problems with thinking and memory
Tiredness (fatigue)
Pain

The researchers felt that most of these side effects were due to people’s cancer and not because of the treatment

So, pregabalin is not useful for people with pain caused by cancer in their bones.

The researchers would like to see more trials for people with advanced cancer. They also think that pregabalin could possibly work for people who have bone pain and nerve pain (neuropathic pain). They think a future trial looking at this would be interesting.

We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item ) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.