A trial comparing 2 ways of treating a build up of fluid around the lung (IPC-PLUS)

Cancer type:

All cancer types

Status:

Results

Phase:

Phase 3

This trial compared 2 different ways of treating a build up of fluid around the lung caused by cancer.

This trial closed in 2016 and these final results were published in 2018.

More about this trial

In some people who have cancer, fluid collects between the sheets of tissue covering the outside of the lung and the inside of the chest wall. These sheets of tissue are called the pleura. The collection of fluid is called a pleural effusion.

To treat a pleural effusion, doctors put a tube into your chest to drain away the fluid. They can also do a procedure called talc pleurodesis. This involves putting sterile talc down the tube into the space between the pleura. This makes them stick together, which can stop the fluid building up again.

An alternative way of treating a pleural effusion is to have a different type of tube called an indwelling pleural catheter (IPC). This can stay in your chest for a while. And it is used to drain off fluid when you are at home.

Half the people taking part in this trial had sterile talc through their IPC.

The other half had sterile salt water (placebo Open a glossary item ) through their IPC. Sterile salt water was used as it would cause no harm.

The aim of the trial was to see if having sterile talc through an IPC was better than having an IPC alone.

Summary of results

The trial team found that having sterile talc through an IPC was better than having an IPC alone.

This phase 3 trial recruited 154 people. Everyone who took part was put into 1 of 2 treatment groups. Neither they nor their doctor could choose which group they were in. It was a randomised trial:

78 people had sterile talc through their IPC
76 people had sterile salt water (placebo) through their IPC

Study diagram

The people taking part didn’t know if they had the sterile talc or sterile salt water through their IPC.

Method
Everyone had a chest x-ray before having the IPC put in. This was to see how much fluid was there to start with.

Then the fluid was drained off at home for the next week. After this the sterile talc or sterile salt water was put in through their IPC.

Their IPC was then drained the following day by the district nurses and at least twice a week (or more if necessary) after this.

Results
The team looked at how much fluid was drained at each visit. Another chest x-ray was taken at each visit.

The pleurodesis procedure was successful if both of the following happened:

the x-ray showed that chest was less than a quarter (25%) full of fluid
less than 50 ml of fluid was drained on 3 occasions in a row

Of the 78 people who had the sterile talc the team were able to look at the results of 69.

Of the 76 people who had the sterile salt water they were able to look at the results of 70.

They found that at day 35 the pleurodesis was successful for:

30 people who had sterile talc (43%)
16 people who had sterile salt water (23%)

Study diagram

At day 70 the pleurodesis was successful for:

35 people who had sterile talc (51%)
19 people who had sterile salt water (27%)

Study diagram

The team looked at the average amount of fluid that was drained from both groups during the trial. This was from the start of the trial to the end at 70 days after treatment. They found it was:

1350 ml for those who had the sterile talc
3640 ml for those who had the sterile salt water

Conclusion

The trial team concluded that sterile talc through the IPC was better than the IPC alone for treating fluid on the lung caused by cancer.

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.