A trial of Lugol’s iodine during surgery to remove abnormal cells from the mouth (LISTER)

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

Cancer type:

Head and neck cancers

Mouth (oral) cancer

Status:

Closed

Phase:

Other

This trial is for people having surgery to remove abnormal cells from the lining of their mouth or part of the throat behind the mouth (oropharynx). This abnormal cell growth is called dysplasia Open a glossary item .

More about this trial

Dysplasia can range from being slightly abnormal to very abnormal. Cancer is more likely to develop in very abnormal cells.

We know that removing these abnormal cells can reduce the risk of cancer developing. But it is often difficult for surgeons to clearly see where the abnormal cells end and normal cells begin.

Lugol’s iodine has been used in other parts of the body to show where abnormal cells are. Researchers think it might help surgeons during surgery to remove dysplasia from the mouth and part of the throat behind the mouth. Areas of dysplasia can be called lesions.

To find this out researchers need to do a clinical trial with a large number of people. But before a large clinical trial can be done they need to find out if people are willing to take part. This is called a feasibility study.

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.

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

Have abnormal cell growth (dysplasia) of the lining of the mouth or part of the throat behind the mouth (oropharynx)
Are having surgery under a general anaesthetic to remove the dysplasia
Are at least 18 years old

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

Have already had surgery or radiotherapy for a head and neck cancer
Have been diagnosed with a head and neck cancer that is a squamous cell cancer in the past 5 years
Have had another type of cancer in the past 2 years apart from basal cell carcinoma or carcinoma in situ of the cervix

Trial design

This is a feasibility study. The team need 40 people to take part.

The study is randomised. Everyone taking part is put into 1 of 2 groups.

Neither you or your doctor can choose which group you are in. You will not know which group you are in. This is called a blinded trial.

The 2 groups are:

standard surgery with Lugol’s iodine
standard surgery

LISTER trial diagram
For people whose surgeon is using Lugol’s iodine they use it to stain the lesion and the area around it. This shows any abnormal cells that may be around the edge of the lesion. The surgeon will then decide how much surrounding tissue to remove.

For people having standard surgery the surgeon takes out the lesion as usual. They won’t use the stain to look for any more abnormal cells. Instead they’ll remove some tissue from around the lesion, which they normally do.

The researchers will ask you to fill in a questionnaire before surgery and then after at:

6 weeks
3 months
6 months

The questions ask about your general health and wellbeing and if surgery has affected your ability to talk, chew and swallow. This is called a quality of life study. You don’t have to agree to do this. You can still take part in the trial.