Clinical Trials

This page has information about the current clinical trials/clinical outcome research being undertaken at Aintree



This multicenter study aims at estimating the clinical effect of HBO on osteoradionecrosis.


114 patients with mandibular osteoradionecrosis (ORN) stage 2, 3 or 4 are randomised to:

  • Group 1
    • 30 preoperative and
    • 10 postoperative HBO sessions and
    • surgical intervention
  • Group 2
    • surgical intervention without HBO

Each HBO session implies inhalation of 100% oxygen during decompression to 14-15 meters for 90 minutes.

Primary endpoint is healing of bone exposure according to the CTCAE v 3.0 criteria, and is estimated one year after surgery.

Secondary endpoints are quality of life, pain intensity, antibiotics and pain medication, trismus, xerostomia and body mass index.

Following surgery, clinical evaluations are performed at:

  • baseline
  • 1 week
  • 1 and 3 months
  • 1 year

Copenhagen University Hospital is the main centre.

Aarhus, Odense, Liverpool (& other UK units), Gothenburg and Rome are participating centres.

The study is supported by Danish Cancer Association, Danish Cancer Research Foundation and Danish Dental Association.

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HOPON is a randomised clinical trial to discover the value of hyperbaric oxygen (HBO) in preventing jaw necrosis in long term survivors of head and neck cancer. HBO is an additional intensive treatment for patients and needs additional funding on an individual patient basis. Countered against that is the potentially very serious side effect of osteoradionecrosis. Patients having 'surgical procedures' (extractions / implants) in the jaw following radiotherapy are invited to be randomised to HBO (20 dives pre-surgery and 10 dives post-surgery) versus standard care.


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IH-in-surgery.jpgRATIONALE: Surgery may be an effective treatment for oral cancer. It is not yet known whether surgery to remove the tumor and lymph nodes in the neck is more effective than surgery to remove the tumor alone in treating patients with early-stage oral cancer.
PURPOSE: This randomized clinical trial is comparing two types of neck surgery to see how well they work in treating patients with early stage oral cancer

UPDATE 27/07/15: This trial is now closed to recruitment. We will be publishing the results in the near future. Please check back soon or contact Saving Faces for more information

Saving Faces researchers are working on a Cancer Research UK funded study which is the first large scale surgical clinical trial in the United Kingdom for patients with oral cancer. The trial will involve over 600 patients nationwide and aims to answer important questions in the treatment of patients with oral cancer that will benefit both patients and the NHS.  

For patients with early stage oral cancer, surgery to remove the tumour is the first line and usually the only required form of treatment.  Radiotherapy or chemotherapy can sometimes be given after surgery but this is only the case if the tumour is at a more advanced stage.  Like many other forms of cancer, oral cancer can spread and the most common site that oral cancer spreads to is the lymph glands in the neck.  Even where scans and clinical assessments show that there is no evidence of cancer in the lymph glands, there is still about a 30% chance that there will be some microscopic cancer in these glands that cannot be detected.

Read more on the clinical trial

When treating early stage oral cancer when no disease has been detected in the neck, surgeons will remove the mouth tumour and may also decide to take a pre-emptive approach and remove the lymph glands as well (at the same time) to stop the cancer spreading.  Some surgeons will routinely remove the lymph glands at this stage while others may choose to actively monitor the disease and only remove the lymph glands if disease becomes apparent.  Both approaches are standard procedures carried out by surgeons every day but depend on the individual surgeon which treatment they will offer their patient.  As with any surgery there are risks involved with both approaches and these always need to be balanced not only against the chance of curing the disease but also against the benefits and effects on the patient’s quality of life.  However, the fact is that there is no real evidence that one approach is clearly better for the patient than the other.

The SEND trial aims to answer the question of which is the better approach when treating patients with this early stage oral cancer. Patients will have either one of the two treatment options, as they would if they were not in the trial and then followed up closely to monitor their progress.  There are no new or untried procedures in this trial. It simply compares two standard forms of treatment to decide which approach is better for treating patients with this disease.  

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