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.
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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:
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.
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
Other information
This is Cancer Research UK trial number CRUK/10/011.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
