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

Cancer type:

All cancer types




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 Open a glossary item) 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.

Recruitment start:

Recruitment end:

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Marie Fallon

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer

Other information

This is Cancer Research UK trial number CRUK/07/021.

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:


Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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