"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial comparing 2 ways of treating a build up of fluid around the lung (IPC-PLUS)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at 2 different ways of treating a build up of fluid around the lung caused by cancer.
More about this trial
In some people who have cancer, fluid collects between the sheets of tissue covering the outside of the lung. These sheets of tissue are called the pleura. The collection of fluid is called a pleural effusion.
To treat a pleural effusion, doctors can put a tube into your chest to drain away the fluid. They can also carry out a procedure called pleurodesis. This involves putting sterile talc into the tube. The talc gets into the space between the pleura and makes them stick together, which can stop the fluid building up again.
But having pleurodesis can mean that you have to stay in hospital for a few days. An alternative way of treating a pleural effusion is to have a different type of tube called an indwelling pleural catheter (IPC) put into your chest. An IPC can stay in place for a while and can be used to drain off fluid when you are at home.
In this trial, researchers are looking at giving sterile talc via an IPC. The aim of the trial is to see if having sterile talc through an IPC is better than having an IPC alone.
Who can enter
You may be able to enter this trial if you
- Have a build up of fluid around your lung (pleural effusion) due to your cancer
- Are at least 18 years old
You cannot volunteer to join this trial, and you cannot enter if your doctor doesn’t think that having an IPC or pleurodesis would be a suitable treatment for you. As well as this, you cannot take part if you
- Have had previous attempts at sticking the pleura together (pleurodesis) in the last 56 days on the same side of your chest in which you now have a build up of fluid
- Have had an allergic reaction to talc or to a local anaesthetic called lidocaine
- Will not be able to have fluid drained from the IPC at home at least twice a week
- Don’t have access to a telephone
- Are pregnant or breastfeeding
This trial aims to recruit 154 people. Everybody taking part will have an IPC put in. The trial team will make arrangements for you to have fluid drained from the IPC when you are at home. A district nurse will usually do this. But after a certain point in the trial, an appropriately trained relative or carer can do this.
10 days after having the IPC put in, you have a hospital appointment. During this visit you have another chest X-ray and ultrasound. If this shows that your lung can’t expand (trapped lung), you will leave the trial. You will have the care you would have if you were not taking part in the trial.
If your lung has expanded, you will be put into 1 of 2 groups at random. Neither you nor your doctors can decide which group you are in. This is called randomisation.
People in one group have talc put into their IPC. The talc is mixed with sterile salt water (saline).
People in the other group just have the sterile salt water. This is called a
During the trial, the researchers will ask you to fill in a chart each morning to record any pain you have and how breathless you are.
The trial team will also ask you to fill out a questionnaire when you join the trial and at each hospital visit during the trial. The questionnaires ask about any side effects and how you’ve been feeling. This is called a quality of life study.
The researchers may take some samples of the fluid drained from your chest. They will also take some extra blood samples. If you are taking part in the trial in Bristol or Oxford, these samples will be stored safely and may be used for future research.
You will see the trial team and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests
- Chest X-ray
- Ultrasound scan of your chest
You have the IPC put in at hospital and you have another chest X-ray afterwards to check its position. You have some fluid drained off straight away. Most people are able to go home on the same day, but you may need to stay in hospital overnight to be monitored.
You have fluid drained off at home at least 4 more times. Then you see the trial team again10 days later. This visit should not take more than a couple of hours.
Over the next 10 weeks, you have the fluid drained at home at least twice a week and you go to hospital to see the trial team once every 2 weeks, although telephone appointments are possible for 2 out of 5 of these hospital visits.
In total, you will have at least 5 chest X-rays and 5 chest ultrasound scans during the trial. But many of these you would have as part of your normal care.
You may feel sore or bruised after you have the IPC put in, but you have a local
Some people have chest discomfort when the fluid is drained, but this should settle when the drainage stops.
You may have some pain in your chest when the talc is put in. But the trial team will give you painkillers beforehand and you have local anaesthetic at the time to try to reduce this. Talc can also cause a high temperature (fever).
There is a small risk of infection from the procedures.
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.
Dr Nick Maskell
NIHR Clinical Research Network: Cancer
North Bristol NHS Trust