LHM Healthcare Ltd. operating at 2 sites, in Whipps Cross University Hospital in London and James Paget University Hospital in Great Yarmouth has previously participated in all Hyperbaric Studies supported by the British Hyperbaric Association.
At present we are participating in the following:
- HOPON Study.
The most serious side effect of radiotherapy is something called osteoradionecrosis, or ORN for short. This is a condition affecting jaw bones that received radiotherapy in the process of treating cancer of the head and neck. The bones can be damaged by the radiotherapy and do not heal as well as other tissues, because they have a limited blood supply. And the worst case scenario for this particular condition is where the bone dies completely.
It affects patients who have been successfully treated for head and neck cancer and can occur any time after radiotherapy – even 20 years later in some cases. While it can arise spontaneously, it usually develops following dental work, particularly tooth extractions or inserting implants. Loss of bone can lead to patients suffering jaw fractures, experiencing a lot of pain, or having holes (sinuses) appearing in their faces where the jaw bone has collapsed.
Because more people are developing, and surviving, head and neck cancer, we are seeing an increasing number of people with these long term side effects. We think around one in 10 patients who received radiotherapy to the head and neck develops ORN, but we need research to find out exactly how many patients are affected. And for many of these patients, treating ORN is worse than the original cancer treatment. So, as doctors, it is something we are desperately keen to avoid for our patients.
The idea behind the HOPON trial began in the US during 1970s and involved the use of hyperbaric oxygen treatment. People are put in a chamber for a period of time each day, where the oxygen is at higher pressure than in air we normally breathe. It had previously been used in diving accidents, carbon monoxide poisoning and for people with wound healing problems.
The theory was that the increased oxygen re-invigorates damaged tissues and helps them heal quicker. And therefore might help repair jaw bones damaged by radiotherapy, preventing severe side effects from developing after dental surgery in cancer survivors.
A clinical trial was carried out in the early 1980s in Florida. Patients who had been given radiotherapy and later needed dental work were having significantly reduced risk of developing ORN when they receive hyperbaric oxygen therapy before and shortly after their dental procedures. But that original study was a small trial. The time had now come to prove one way or the other if hyperbaric oxygen treatment works in preventing ORN in most patients. And that is the principle behind the HOPON trial.
- DAHANCA Study.
NEW: Greenlight Approval for DAHANCA 21 Study at London Hyperbaric Medicine granted on 17th August 2016
In this study patients who had radiation to the head and neck and then unfortunately developed damage to the jaw bone, called Osteoradionecrosis, will be randomised to have standard treatment with antibiotics and supportive treatment or Hyperbaric treatment with supportive treatment and their surgery to remove the injured jaw bone.
Both these studies are managed primarily by maxillofacial and head and neck surgeons with the assistance of Hyperbaric treatment centres.
3. Studies in development stage
Gas Embolism study
At LHM Healthcare, we have become experts in treating critically ill patients needing Hyperbaric Oxygen as the sole therapy, or part of the therapy of serious medical conditions. We are in the process of setting up a study looking at the incidence and management of patients who had accidental air injected into their circulation. This is called Iatrogenic (complications of medical treatment) Gas (air or any gas used in medical procedures) Embolism, or CGE for short. This unfortunate complication of many medical procedures is difficult to diagnose and the best management at the moment seems to be Hyperbaric Treatment. In order to get this study nationally recognised we need to get research development approval and ethics agreement. Part of this process is to ensure enough funding to complete this study which is fortunately not a very expensive project. The London Hyperbaric Charity may assist with a research fund being set up at the moment to assist with this funding.
Severe Carbon monoxide poisoning study
A second research project that we are in the process of setting up is looking at the outcome of patients treated with Hyperbaric Oxygen for severe carbon monoxide poisoning. This project has been submitted to the NIHR – National Institute of Health Research, for consideration.
Sudden Hearing Loss study
A further study we are planning at the moment is a project to compare the outcome of patients with sudden hearing loss. Hyperbaric Oxygen treatment has been approved for this serious and debilitating condition in Europe and the United States but so far the NHS does not support that. In order to get better information and hopefully agreement to fund this conditions treatment we are looking at setting up a study for this condition. If the condition is accepted for hyperbaric treatment in the UK, then specialists will refer these cases early on in good time to benefit from hyperbaric oxygen.
Most patients who are unconscious and being ventilated in a hyperbaric chamber as part of the treatment, are recommended to have grommets in their eardrum. These are tiny drainage tubes to allow the air to move in and out of the middle ear when the pressure changes in the hyperbaric chamber. This is to avoid trauma from the pressure in the hyperbaric chamber, but there is some doubt whether it is justified to delay treatment to have this procedure done. We are working with our colleagues abroad to set up an observational study to get clarity on the best practice in this situation.