A study to try and work out when fluid around the lungs comes back (REPEAT)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

All cancer types

Status:

Closed

Phase:

Other

In this study researchers want to find out how long it takes for fluid around the lungs to come back after treatment.

It is open to people with fluid on the lung that is caused by cancer or your doctor thinks it might be caused by cancer.

More about this trial

People who have cancer can get fluid on the lungs. The fluid collects between two sheets of tissue that cover each lung. This is a pleural effusion Open a glossary item .

Diagram 1

To treat a pleural effusion doctors drain the fluid away. They do this by putting a needle into the space between the pleural membranes. This is a pleural tap Open a glossary item .

For some people the fluid builds up again. People do ask their doctor how long this might be if it happens to them. Unfortunately at the moment doctors can’t give them an answer.

In this study researchers want to find out how long it might take for the fluid to start building up again. To do this they will ask people who are having treatment some questions. They will also take some samples of the fluid and some blood samples.

The aim of this study is to look for substances (biomarkers Open a glossary item ) in the samples to see if they can work out when the fluid is starting to build up again.

Please note you won’t benefit directly if you take part in the study. But it might help people in the future who have a pleural effusion.

Who can enter

The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

Who can take part

You may be able to join this study if all of the following apply. You:

have fluid on the lung that is caused by cancer or your doctor thinks cancer might be the cause
have had an ultrasound or a CT scan that shows you have fluid on the lung
have a certain amount of fluid drained when you have the fluid removed. Your doctor will know about this.
are at least 18 years old

Who can’t take part

You cannot join this study if any of these apply. You:

have an infection of the tissue covering the lungs (pleura) or another condition that needs you to go into hospital to have a tube put into your chest to drain fluid
have fluid on the lung that your doctor thinks isn’t caused by cancer
are pregnant or breastfeeding
have any other medical condition, mental health problem or social situation that your doctor thinks could affect you taking part

Trial design

This is an observational study. The team need 240 people to join.

When you go to the hospital to have the fluid drained a member of the team will ask you a few questions. They’ll ask about the symptoms you have.

You then have the fluid drained. The doctor sends the fluid to the laboratory for analysis.

You come back a week later for the results. You might have more fluid drained off if this is necessary. Your doctor will talk to you about this.

Tests and samples for research
The study team measure how much fluid is drained.

They also want to measure the pressure in the pleural space. They do this while the doctor drains the fluid. There is no risk to having this done. You can say no to this part of the research if you don’t want it done.

The team will ask for some blood samples and extra samples of the pleural fluid. They take them when your doctor takes samples as part of your routine care. Your doctor will tell you how often these are taken and when.

They will use these samples to:

look for substances (biomarkers ) that might tell them how fast the fluid is building up
learn more about fluid on the lung

You can say no to giving these extra samples if you don’t want to give them. It won’t affect you taking part in the rest of the study.

Quality of life
You have a diary to fill in during the week after you have the fluid drained. In the diary you mark on a horizontal line how breathless you feel each day. Your doctor will tell how to do this.

You bring the diary back when you see the doctor a week later.

You also fill in a questionnaire:

when you agree to join the study
the week after the fluid is drained
then 3 months later. This is done during a phone call.

The questions ask about:

your health and general wellbeing
what you are able to do
any pain or discomfort
any anxiety or depression you might have

This is a quality of life questionnaire.

Hospital visits

You see the doctor before taking part. This is to tell you about the study and ask a few questions about how breathless you are.

You then have the fluid drained. After this you have a chest x-ray and ultrasound of the chest.

A week later you see the doctor and have another chest x-ray.

You don’t have any extra hospital visits if you take part in this study. These visits are all part of your routine care.

A member of the study team will phone 1 month and 3 months after your treatment. They will ask how you are and about any further treatments you might have had.