A trial of electrocautery ablation to prevent lung cancer (EARL)

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

Cancer type:

Lung cancer

Status:

Closed

Phase:

Phase 2/3

This trial is looking at treating areas of abnormal cells in the lungs with an electric current (electrocautery) to prevent lung cancer.

Cancer Research UK supports this trial.

More about this trial

Symptoms of lung cancer can include:

coughing most of the time
coughing up phlegm (sputum) with blood in it
getting out of breath

Your doctor will arrange for you to have some tests if needed to find out if it is cancer or not. These can include testing your sputum or taking a small tissue sample (biopsy Open a glossary item ).

These tests might show that you have abnormal areas of cells that aren’t cancer but could develop into cancer. As part of your management, your doctor might arrange for you to have a bronchoscopy every few months so they can check if these abnormal cells develop into cancer over time.

In this trial researchers want to see if treating these abnormal cells with electrocautery might stop them developing into cancer. Electrocautery is performed during bronchoscopy.

EARL Diagram 1

To treat the areas of abnormal cells, an electric current passes through the bronchoscope. The electric current then burns the area of abnormal cells.

To find out how well it might work, some people in the trial will have electrocautery and some people won’t.

Everyone will have regular bronchoscopies during the trial.

The team will compare the results of the 2 groups to find out how well electrocautery might work to stop abnormal cells in the lung developing into cancer.

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial 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 trial if all the following apply. You:

have at least 1 area of abnormal cells in your airway that have a high risk of becoming cancer (high grade )
are active for at least half the day but might not be able to work (performance status 0, 1 or 2)
have lungs that are working well enough
are willing to have tissue samples and blood samples taken as part of the trial
are at least 18 years old

Who can’t take part

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

have a CT scan that shows you have a primary lung cancer
have a tissue sample (biopsy ) taken from your airway during bronchoscopy that shows you have cancer
have had abnormal airway cells for 5 years or more
have an area of abnormal airway cells that is bigger than 3cm in length
have another cancer apart from basal cell skin cancers
are having chemotherapy
have had previous radiotherapy to where the abnormal cells are
are taking blood thinning medication such as warfarin because you have an artifical valve in your heart
have liver or kidney problems
have taken an experimental drug as part of another clinical trial within a month of joining this trial
have any other medical condition or mental health problem that your doctor or the trial team think could affect you taking part
are pregnant

Trial design

This is a phase 2/3 trial. The team need 111 people to join the trial.

It is a randomised trial. You go into 1 of 2 groups. Neither you nor your doctor can choose which group you are in. The groups are:

bronchoscopy (AFB)
AFB and electrocautery (EC)

You have twice as much of a chance going into the AFB and EC group than the AFB group.

EARL Randomisation Diagram 1

AFB
Autofluorescence bronchoscopy is the same as a bronchoscopy except that it uses a blue light instead of a white light. The blue light highlights the areas of abnormal cells better than the white light.

You have a general anaesthetic Open a glossary item for this. It takes about 45 minutes. You have AFB as an outpatient.

EC
For electrocautery you have an AFB as usual. Electrocautery uses an electric current to destroy the areas of abnormal cells. The electric current goes out from a probe that is passed through the bronchoscope. The electric current burns the area of abnormal cells.

You might need to have more than 1 treatment. Your doctor will tell you about this.

You have a general anaesthetic for this. It takes about 45 minutes. You have EC as an outpatient but you might need to stay overnight in the hospital.

During the trial everyone has regular AFB to keep a watch on the areas of abnormal cells.

Patient diary and Quality of life
You have a diary to record any symptoms you might have and medications you take. You bring this diary with you to every clinic appointment for the doctor to see.

You fill in a short questionnaire when you join the trial, during the trial and at the end of the trial. The questions ask about how you are feeling. This is a quality of life questionnaire.

Research samples
You give a blood sample. During your regular AFB the researchers take samples of tissue.

For patients of UCLH you also give cell samples from your:

nose using a nasal swab (nasal brushings)
airway during the AFB (bronchial brushings)

Patients at some other hospitals might also need to give these samples.

Researchers will use these samples to try and find out why the abnormal cells in some people becomes cancer.

Hospital visits

You see the doctor to have tests before taking part. These tests include:

physical examination
blood tests
breathing test (lung function test )
CT scan

You have your 1st electrocautery treatment a month after randomisation Open a glossary item . You then have an autofluorescence bronchoscopy a month later. This is to check whether you might need another EC treatment.

You have an AFB at:

6 months
1 year
2 years
3 years

You have a CT scan and breathing test at:

1 year
2 years
3 years

Side effects

The trial team monitor you during treatment and afterwards. Contact your doctor or nurse if any side effects are bad or not getting better.

After autofluorescence bronchoscopy you might cough up blood stained spit (sputum) for a couple of days. If it continues after this or you cough up a large amount of blood contact your healthcare team straight away.

People who have a breathing problem such as chronic obstructive pulmonary disease (COPD) might find that electrocautery can make it worse. Tell your doctor or nurse if this happens.

The most common side effects of having bronchoscopy are: