A trial looking at using a dye during surgery for mouth and throat cancer (LIHNCS)

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 looking at using a dye made from iodine during surgery to remove cancer of the mouth or part of the throat just behind the mouth (oropharynx). This dye is called Lugol’s iodine stain. This trial is supported by Cancer Research UK.

Doctors can treat cancer of the mouth and throat with surgery. During surgery, they can see where the cancer stops and where normal tissue begins. But there may be some abnormal (pre cancerous) cells around the area that the doctor cannot see. And if these are left behind, they could develop into cancer.

Doctors use Lugol’s iodine stain to show where these abnormal cells are when they operate to remove cancer from other parts of the body.

We know from a small study that doctors may use Lugol’s iodine stain in the same way when removing mouth and throat cancer with surgery. The researchers want to do a trial with bigger numbers of people to make sure that this is so.

The aim of this trial is to find out if using Lugol’s iodine stain can lower the number of abnormal cells left after surgery for cancer of the mouth and throat.

Who can enter

You can enter this trial if you

Have cancer of the mouth or part of the throat just behind the mouth (oropharynx) that is of the most common type called squamous cell
Are having surgery to remove your cancer

You cannot enter this trial if you

Have cancer that has spread to another part of the body – you may take part if your cancer has spread to the lymph nodes in your neck
Have had surgery, radiotherapy or chemotherapy for your cancer, or another type of head and neck cancer, before
Have had another cancer in the last 5 years – you may join the trial if you have had basal cell skin cancer or carcinoma in situ of the cervix
Are allergic to iodine
Have taken part in the Lugol’s or LIHNCS trial before

Trial design

This trial will recruit about 410 people. It is a randomised trial. You are put into 1 of 2 treatment groups by a computer. Neither you nor your doctor can choose which group you are in. Everyone taking part in the trial will have surgery.

If you are in group 1, before removing your cancer the surgeon will use Lugol’s iodine stain on the cancer and the area around it. This is to show any abnormal cells that may be around the edge of the cancer. The surgeon will then decide how much tissue to remove with the cancer.

If you are in group 2, the surgeon will take out the cancer as usual but not use the stain to look for any abnormal cells. Instead they will remove some tissue from around the cancer, which they normally do.

The researchers will ask you to fill in a questionnaire about how you are feeling and any symptoms you have had. You fill it in before surgery and at 6 weeks, 6, 12 and 24 months after your surgery. This is called a quality of life questionnaire.

Hospital visits

There are no extra hospital visits if you take part in this trial.

Side effects

The stain used in the trial contains iodine. Please discuss this with your doctor if you think you may be allergic to iodine.

Recruitment start:

29/11/2010

Recruitment end:

31/10/2013

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.

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

Chief Investigator

Dr James McCaul

Supported by

Bradford Teaching Hospitals NHS Foundation Trust
Cancer Research UK
NIHR Clinical Research Network: Cancer
Warwick Medical School Clinical Trials Unit