A trial looking at 2 ways to treat a build up of fluid around the lung (OPTIMUM)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is comparing two ways to treat a build up of fluid around the lung. It is for people who have a build up of this fluid because of their cancer.
The lung is covered with 2 sheets of tissue called the pleura. These normally produce a small amount of fluid which lubricate the lungs and helps us to breathe. When cancer spreads to the pleura it causes too much fluid to be made. This collection of fluid is called a pleural effusion.
More about this trial
A pleural effusion stops the lungs expanding properly and this makes it more difficult for people to breathe. A doctor can put a tube called a chest drain into the space between the 2 pleura (called the pleural space). This drains off the extra fluid, helping a person to breathe more easily. But the fluid can build up again.
Doctors can try and prevent this from happening by putting sterile talc into the pleural space. This is called pleurodesis. This helps the pleura stick together and so there is no space for the fluid to collect.
Another way to treat a pleural effusion is to put a small plastic tube called an indwelling pleural catheter (IPC) under the skin into the pleural space. A connection on the end of this tube means that a district nurse or carer can attach a bottle onto the connection to drain off the fluid when needed. A doctor can also inject sterile talc in between the pleura through this connection.
You usually have to stay in hospital when you have a chest drain and pleurodesis. You do not have to stay in hospital if you have an IPC.
Both treatments are safe and widely used, but a trial has not so far directly compared the following two treatments.
- A chest drain and pleurodesis
- An indwelling pleural catheter and pleurodesis
The aim of this trial is to find out which is better at improving a person’s quality of life.
Who can enter
You may be able to join this trial if all of the following apply. You
- Have a build up of fluid around your lung (pleural effusion) due to cancer and your doctor thinks this should be treated
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Are at least 18 years old
You cannot join this trial if any of these apply
- You have a build up of fluids that has collected in pockets of fluid (making draining the fluid more difficult)
- Your symptoms have not improved despite previous drainage of your pleural effusion
- You are not fit or well enough to have the fluid drained off (at least twice a week) through an indwelling pleural catheter at home
- You are allergic to the sterile talc or local anaesthetic used in this trial
- You have a type of cancer called small cell cancer or lymphoma and you are having treatment with the aim of curing your disease. You may be able to take part if you have either of these cancer types and chemotherapy treatment has not worked, or you are having treatment to control symptoms (palliative treatment)
- Are pregnant or breast feeding
Trial design
The researchers need 142 people to join this trial. If you are a patient at one of the recruiting hospitals you may be asked to take part by your doctor.
It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
- One group have a chest drain and pleurodesis
- The other group have an indwelling pleural catheter (IPC) and pleurodesis
Before you have treatment, you will have an ultrasound scan of your chest so that your doctor can decide where to put the chest drain or IPC in. This is usually at the side of your chest. You then have local anaesthetic to numb this area. Your doctor will explain in more detail what will happen during your procedure.
If you have a chest drain, you stay in hospital for about 5 days to let the fluid drain sufficiently and to have the sterile talc inserted (pleurodesis). Your chest drain is then taken out and you can go home. You go back to hospital 1 week later so your doctor can see how you are and check that the treatment has worked.
If you have an IPC you have this procedure as a day patient. The IPC stays in place when you go home. A district nurse will visit your home regularly to drain the fluid away. Or you may be taught to do this yourself if you are willing and able to do it. You may need to do this once a day at first, then becoming less frequent (for example, 3 times a week).
You go back to hospital 3 days later so that your doctor can check that your lung has expanded enough to have sterile talc put into the pleural space. If you have talc treatment, you go to hospital 4 days later to see a doctor so they can see how you are and see if the treatment has worked.
People in both groups visit hospital to see a doctor and have a chest X-ray and ultrasound after
- 2 weeks
- 1 month
- 2 months
- 3 months
If you have an IPC and you don’t have problems with fluid returning, your doctor may remove your IPC at 1 of the appointments above.
The trial team will ask you to fill out a questionnaire before your procedure and at each of your hospital visits. The questionnaire will ask about any symptoms you have and how you are. This is called a quality of life study.
Hospital visits
If you have a chest drain and talc treatment you have a total of 6 hospital visits. You stay in hospital for about 5 days for your first visit and all your other appointments will be as an out patient.
If you have an IPC and possible talc treatment, you have a total of 7 hospital visits. You will not have to stay in hospital overnight.
Side effects
A chest drain, an indwelling pleural catheter (IPC) and talc treatment are all routine procedures widely used by doctors. Most people feel better after their treatment but you may have some discomfort and pain during and after your procedure. You will be given some painkillers and this usually settles down with time.
There is a small risk of infection. Every precaution is taken to prevent this from happening. You will have antibiotics to treat this if necessary.
There is a small chance of the chest drain or IPC procedure causing air to leak from the lung. This is called a pneumothorax. If this happens you will need to stay in hospital for a few days to have treatment for this.
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.
Chief Investigator
Dr. Liju Ahmed
Supported by
CareFusion Ltd
Guy’s and St Thomas’ NHS Foundation Trust.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
