A trial looking at using urokinase to help drain fluid from around the lung - TIME3 UK

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:

Phase 3

This trial is looking at using urokinase to help drain more than 1 pocket of fluid from around the lung, to make breathing easier.

Some people with cancer may have fluid collect between the lung and chest wall. This fluid takes up space that your lung would normally expand into when you breathe in. This can make breathing difficult and make you short of breath. This is called pleural effusion.

Doctors can treat this by draining the fluid away. They do this by putting a tube into the space between the chest wall and lung. After draining the fluid, they may also put in talc to stick the lung to the chest wall and stop more fluid collecting. This is called pleurodesis.

But sometimes there is more than 1 pocket of fluid between the lung and chest wall. This makes it difficult to drain all the fluid away.

Urokinase is a drug that may help break down these pockets. This may help doctors drain the fluid from around the lung better.

The aim of this trial is to compare urokinase with a dummy drug (placebo) to see if it

  • Can help control and improve shortness of breath caused by pleural effusion
  • Can improve the success rate of pleurodesis

Who can enter

You can enter this trial if you

  • Have more than 1 area of fluid between the lung and chest wall (pleural effusion) that is caused by cancer
  • Are in hospital with a drain in your chest to drain fluid but the drain is not working
  • Are at least 18 years old

You cannot enter this trial if you

  • Have had surgery to remove your lung
  • Have had major surgery in the past 5 days
  • Have had an infection of the lining between the lung and chest wall in the last 4 weeks
  • Are allergic to urokinase
  • Have had a stroke, an injury or a large amount of bleeding in the past 4 weeks
  • Have a low number of platelets in your blood or another medical condition that can cause bleeding problems
  • Have problems with your sight
  • Are pregnant or breastfeeding

Trial design

This trial will recruit 126 people throughout the UK.

There are 2 groups in this trial. It is a randomised trial. Neither you nor your doctor can choose which group you are in. Half the people will have urokinase. The other half will have the dummy drug (placebo).

Both the urokinase and placebo are fluids. The doctors will put the fluid into the space via the tube you already have in your chest. They will do this every 8 to 14 hours for a total of 3 treatments. They will then allow the fluid to drain away. And between each treatment the tube is open so that any fluid is able to drain away.

After the 3 treatments, you will have talc put in the space between the lung and chest wall to try and stop more fluid collecting there.

For 28 days after this, you will fill in a form to assess your breathing. You do this at home, but someone will go over it with you before you leave hospital. After treatment, you will see the doctor at 1, 3, 6 and 12 months in the outpatients department.

At each appointment you are asked to fill in a questionnaire. It will ask how you are, and about your breathing.

Hospital visits

To take part in this trial, you will already be in hospital and would have had the following tests

The trial will last about 3 days. You will go home when you are well enough.

Side effects

Urokinase could cause an increase risk of bleeding in the space between the lung and chest wall.

Talc can cause fever, chest pain and may lower the level of oxygen in your blood.

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Naj Rahman

Supported by

Medical Research Council (MRC)
NIHR Clinical Research Network: Cancer
National Cancer Research Institute (NCRI)
Oxford Respiratory Trials Unit
Syner-Med PLC
University of Oxford

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle - 3169

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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