A trial looking at fentanyl nasal spray to treat breakthrough cancer pain

Please note this trial is no longer recruiting patients.

This trial will compare fentanyl citrate nasal spray (also called NasalFent) with other painkillers that are already used to treat cancer pain.

Pain can be there all the time and long lasting. Doctors often call this ‘background’ pain. If a person has background pain they will usually have regular slow release painkillers, usually morphine or a similar opioid drug. Breakthrough pain is a different type of pain which ‘breaks through’ these regular painkillers. Breakthrough pain can appear suddenly and can be very severe. It can be unexpected and happen for no apparent reason. Or it can be caused by movement, such as changing position, or even just coughing.

Breakthrough pain is best treated with painkillers that work quickly (such as immediate release morphine). The treatment in this trial is a known painkiller (fentanyl) that is being tried in a new way - as a nasal spray - to treat this type of pain.

This trial will recruit people who have regular painkillers for cancer related pain, but who also need quick acting pain relief to get rid of breakthrough pain. It will compare fentanyl nasal spray with a morphine painkiller you take by mouth to see which is best at controlling or getting rid of breakthrough pain. Doctors want to find out if the nasal spray works more quickly than a morphine tablet.

Recruitment

Start 01/05/2007

End 31/03/2009

Phase

Phase 3

Who can enter

You can enter this trial if you

Have been diagnosed with any type of cancer that is causing you pain
Take a total dose of at least 60 mg of regular opioid pain killers in 24 hours for cancer related pain and have been on this dosage for at least 7 days already
Usually have 1 to 4 episodes of breakthrough cancer pain, most days, and this breakthrough pain is relieved by standard pain control. For example, morphine, such as Oramorph taken every 4 hours
Are well enough to be up and about for at least half the day
Are willing and able to keep a record of when you have pain and how bad it is
Are at least 18 years old or above
Are willing to use contraception if there is a chance that you or your partner could become pregnant

You cannot enter this trial if

You cannot take opioid drugs, including fentanyl, because you get bad side effects for example
You have uncontrolled pain or pain that is getting increasingly worse (do speak to your doctor or nurse if your pain is not being controlled with your painkillers)
Your pain is due to another medical condition, such as arthritis
You are pregnant

Trial design

This trial will recruit patients from 8 different countries in Europe. If you take part, the study doctor and study staff will show you how to use the fentanyl nasal spray (NasalFent). You hold the bottle to your nostril and squeeze the finger grips on the bottle. You will also have pictures to show you what to do.

First of all, the study staff need to find out the right dose of NasalFent for you. They will give you two bottles of NasalFent to use at home to treat your breakthrough pain. You will also continue to have your slow release painkillers as normal. The study staff will then telephone you every day for up to 14 days. They will ask you

If you have breakthrough pain
How you are getting on with the nasal spray
If it is relieving your breakthrough pain

The answers to these questions will help the study staff work out what the best dose is for you. They will explain to you

What dose to take
When to use the spray
How often to take it

Once the study staff have found a dose of NasalFent that works for you, you will start the treatment on trial. The study staff will give you bottles of nasal spray and packets of tablets to take home. Each bottle and tablet will be labelled with a number.

When you start to have breakthrough pain at home, you take a study nasal spray and a tablet at the same time. You will have nasal spray number 1 and tablet number 1 for your first episode of pain. Then nasal spray number 2 and tablet number 2 for your second episode of pain, and so on. You will always have a painkiller to control your pain, you will just not know if the painkiller is in the nasal spray or the tablet.

The study staff will give you a palm pilot which has an electronic multiple choice questionnaire to fill in. Each time you use a dose of the study nasal spray and the tablet, you will record your answers on this questionnaire. The study staff will show you how to use the palm pilot to record these answers. The palm pilot is similar to an electronic diary and is easy to use.

You will take the study nasal spray and tablets for up to 6 weeks. When you have finished this trial, you can continue taking fentanyl nasal spray for breakthrough pain. Or you can return to taking the painkillers you were taking before the trial started. Your doctor will discuss this with you.

Hospital visits

Before you start your treatment a doctor will examine you. This will include an examination of your nose to make sure that a nasal spray will work for you.

You will have your blood pressure and heart rate (pulse) measured, as well as some blood tests and a urine test. You will have these all again at your last hospital visit.

As a result of taking part in this study, you will visit your hospital 4 times over about 6 weeks.

Side effects

The most common side effect of NasalFent is likely to be irritation of your nasal passages, causing a runny nose. The other side effects of NasalFent are similar to those of the immediate release morphine tablets that you will also be taking. These side effects include