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A trial looking at stents to relieve breathlessness in people with non small cell lung cancer (RESTORE - AIR)

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

This trial is trying to find out if using a tube called a bronchial stent to open up a blocked airway will help relieve breathlessness in non small cell lung cancer (NSCLC).

Sometimes, lung cancer can partly or completely block the main airways of the lungs (the windpipe or main bronchus). This can cause shortness of breath.

Usually, doctors recommend using a bronchial stent to control symptoms if radiotherapy or chemotherapy has not controlled the growth of the cancer, or if you cannot have these treatments. At the moment, stenting is not generally the first treatment offered. Doctors think that using a stent before any other treatment may relieve breathlessness.

This trial aims to find out if using a stent to open up your airway

  • Will help your breathlessness
  • Will make it easier for you to cope with other treatment you may have for your cancer

The researchers will also look at whether a bronchial stent improves your quality of life. For example, whether it helps with daily activities such as walking.

Recruitment

Start 01/09/2008
End 14/10/2010

Phase

Phase 3

Who can enter

You can enter this trial if you

You cannot enter this trial if

  • You are unable to have a stent for medical reasons
  • You are pregnant
  • Your cancer can be removed with an operation

Trial design

This phase 3 trial aims to recruit 60 people with non small cell lung cancer (NSCLC).

There are 2 groups in this trial. The trial is randomised. The people taking part are put into the different groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

If you are in group 1, you have a stent put in to open up the blockage in your airway. This is done via a bronchoscopy under a general anaesthetic, so you are unconscious. You have a tube put down your throat into your airway. The doctor passes the stent into this tube and places it in the area of the blockage. The stent will expand slightly over the next couple of days and open up the airway.

There is a small possibility that you when you have the bronchoscopy you won’t need a stent, or that the doctors won’t be able to put a stent in to open up the blockage. The doctors will discuss this with you in more detail if it happens.

If you are in group 2, your doctor will treat your symptoms in the standard way. For example, your doctor may recommend that you have chemotherapy or radiotherapy. You will not have a stent at the moment.

If you have a bronchoscopy, the trial doctors will ask for some samples of your cancer that they will take during this test. The researchers will look at these samples to understand more about the causes of lung cancer and why some people respond to treatment, and some don’t.

They will also ask you for extra blood samples. These will be taken at the same time as routine blood tests, so you will not have any extra needles. This part of the trial is optional. You do not have to agree to these extra tests if you don’t want to. You will still be able to take part in the trial.

Hospital visits

If you agree to take part, you have various tests and assessments at the start of the trial. These include

  • Lung function tests
  • A walking test - you walk at your own pace for 6 minutes with rests if necessary and the trial nurse measures the distance you cover
  • Blood tests

One of the blood tests is called a blood gas analysis. This measures the amount of certain gases, such as oxygen, in the blood stream. Blood for this test is taken from an artery in your wrist.

You will be asked to fill in 3 questionnaires about your quality of life, for example, your symptoms and daily activities. You will also rate how severe your symptoms are on a scale called a visual analogue scale.

If you are in group 1, you stay in hospital for 1 or 2 nights to have your stent put in. Everyone in group 1 will have this done at St George’s Hospital. Before you go home, you have another walking test.

Everyone in this trial will have some of these tests and assessments repeated about 2 weeks after joining the trial and again at 3 months. You will visit the hospital for these appointments. A trial doctor or nurse will telephone you after 6 weeks to ask about any breathlessness you are having.

Side effects

The most common side effect of having a bronchoscopy and a bronchial stent is a sore throat. This happens in about 30 out of every 100 people (30%).

The side effects of a general anaesthetic used for a bronchoscopy are usually mild and last for a few hours. These include feeling sick, a headache and muscle aches. Your doctor will talk to you in more detail about common and less common side effects of this procedure.

The blood test taken from your wrist (blood gas analysis) can be painful. An experienced doctor will do this. They will make sure it is as quick and painless as possible.

Location of trial

CLOSED

For more information

Please note: we cannot help you to join a specific trial. Unless we state otherwise in this trial summary, you need to print this page and take it to your own doctor to discuss.

Find out how to join a trial or contact our cancer information nurses for other questions about cancer by phone (0808 800 4040), by email, or at

The Information Nurses
Cancer Research UK
Angel Building
407 St John Street
London
EC1V 4AD

Chief Investigator

Dr M. O’Brien

Supported by

Marie Curie Cancer Care
National Institute for Health Research Cancer Research Network (NCRN)
St George's Healthcare NHS Trust
The Royal Marsden NHS Foundation Trust
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Updated: 9 November 2010