A trial looking at high pressure oxygen to treat damage to the jaw bone (DAHANCA 21)

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

Cancer type:

Head and neck cancers

Laryngeal cancer

Mouth (oral) cancer

Nasal and paranasal sinus cancer

Nasopharyngeal cancer

Pharyngeal cancer

Salivary gland cancer

Status:

Closed

Phase:

Phase 3

This trial is looking at high pressure oxygen therapy (hyperbaric oxygen therapy) to treat damage to the jaw bone caused by radiotherapy.

This trial is supported by Cancer Research UK.

More about this trial

Radiotherapy is one of the main treatments for cancer. It works by causing damage to the DNA Open a glossary item in cancer cells. Although some of the normal cells are affected by the radiation they are better at repairing themselves than the cancer cells.

If you have radiotherapy to your head and neck, it may cause a breakdown of tissue in the jaw bone. This is called osteoradionecrosis Open a glossary item (pronounced oste-o-rade-o-ne-krosis). If the damage is bad enough to cause symptoms, your doctor may suggest surgery to remove the damaged jaw bone.

High pressure oxygen therapy may help the bone to heal after surgery. But this isn’t known for sure.

In this trial, half the people will have high pressure oxygen therapy before and after surgery to remove the damaged part of their jaw bone. The other half will have surgery only.

The main aim of the trial is to find out if high pressure oxygen therapy can help the healing of the jaw bone after surgery.

Who can enter

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

Have had radiotherapy to your lower jaw bone and it hasn’t healed properly or a part of your jaw bone is exposed
Need surgery to your jaw bone
Are at least 18 years old

If you are a woman, you must also be willing to use reliable contraception during the trial if there is any chance you could become pregnant.

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

Have already had high pressure oxygen therapy
Have another cancer or there is still some cancer left in your head and neck area
Are not able to be in confined places (you are claustrophobic)
Have fluid on your chest (pleural effusion ) that hasn’t been drained
Have high blood pressure that isn’t controlled by medication
Have a medical condition that could affect you taking part
Have a titanium device in place that was used to help reconstruct the part of your jaw that is exposed (your doctor can tell you this)
Are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. The researchers need 114 people to join the trial.

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

People in group 1 will have surgery to remove the damaged part of their jaw.

People in group 2 will have high pressure oxygen therapy (hyperbaric therapy) before and after their surgery to remove the damaged part of their jaw.

DAHANCA 21 trial diagram

Everyone has their surgery as planned by their surgeon.

If you are in group 2, you have high pressure oxygen therapy in the treatment centre that is closest to you. As there are only 5 such centres in the UK you may have to travel quite a distance for the treatment.

You have 30 treatments before surgery and 10 treatments after surgery. You have your treatments Monday to Friday. The treatment lasts for 1½ hours each day. You have it as an outpatient so you can go home afterwards.

The trial team will ask you to fill out a questionnaire before surgery, a week later, then 1 month, 3 months and a year after surgery. The questionnaires will ask about side effects and how you’ve been feeling. This is called a quality of life study.

If you take part in this trial, the researchers will ask for a sample of spit (saliva) and a blood sample after surgery and a year later. They will use these to look for substances (biomarkers Open a glossary item ) that may be a sign of a lack of oxygen.

They will also take a photograph of your jaw when you join the trial and another one a year later. It will not be possible to identify you from these photos.

Hospital visits

You see the doctor and have some tests before taking part in the trial. These tests include

A physical examination
An examination of your mouth and teeth
X-ray of your teeth and mouth

You see the doctor 1 month, 3 months and a year after surgery. You have the same tests again each time.

Side effects

The side effects of high pressure oxygen therapy include

Tiredness
Mild changes in vision (this should return to normal within 3 months of finishing treatment)
Pain in your ear or damage to your eardrum (this is rare)
Fits (this is very rare)

Your doctor will talk to you about the possible complications of surgery and side effects of high pressure oxygen therapy before you agree to take part in this trial.