Efficacy of Hyperbaric Oxygen Therapy in the Treatment of Osteoradionecrosis
Summary
The purpose of this study is to determine whether hyperbaric oxygen therapy is effective in the treatment of osteoradionecrosis (late damage after radiotherapy) of the jaw.
Description
Late radiation damage to the lower jaw (osteoradionecrosis (ORN)) is often seen in patients treated with radiotherapy for a tumor in the head and neck region. Part of the lower jaw becomes non-vital and has to be treated. ORN proofs to be a condition difficult to treat and the treatment for this condition varies.
In many countries hyperbaric oxygen therapy (HBOT) is added to the surgical treatment of ORN. Unfortunately there is no consensus whether the addition of hyperbaric oxygen therapy to the treatment of ORN is beneficial or not. This study has the aim to investigate the efficacy and cost-effectiveness of HBOT in the treatment of ORN
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Osteoradionecrosis
Intervention
medical oxygen
Location
NKI/AvL
Amsterdam
Netherlands
1066CX
Status
Recruiting
Source
Radboud University
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00989820
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Osteoradionecrosis
Necrosis of bone following radiation injury.
Oxygen Consumption
The rate at which oxygen is used by a tissue; microliters of oxygen STPD used per milligram of tissue per hour; the rate at which oxygen enters the blood from alveolar gas, equal in the steady state to the consumption of oxygen by tissue metabolism throughout the body. (Stedman, 25th ed, p346)
Oxygen Isotopes
Stable oxygen atoms that have the same atomic number as the element oxygen, but differ in atomic weight. O-17 and 18 are stable oxygen isotopes.
Reactive Oxygen Species
Molecules or ions formed by the incomplete one-electron reduction of oxygen. These reactive oxygen intermediates include SINGLET OXYGEN; SUPEROXIDES; PEROXIDES; HYDROXYL RADICAL; and HYPOCHLOROUS ACID. They contribute to the microbicidal activity of PHAGOCYTES, regulation of signal transduction and gene expression, and the oxidative damage to NUCLEIC ACIDS; PROTEINS; and LIPIDS.
Oxygen Radioisotopes
Unstable isotopes of oxygen that decay or disintegrate emitting radiation. O atoms with atomic weights 13, 14, 15, 19, and 20 are radioactive oxygen isotopes.
Clinical Trials
ORN Study: Curative Treatment of Osteoradionecrosis (ORN) With Hybrid Bone Substitution
The main objective of the study is the cure of osteoradionecrosis (ORN) at 12 months.
Objectives: The objective of this study is to determine if any differences exist between the varying modes of portable oxygen delivery systems including liquid oxygen, a portable concentr...
Use of 50% Nitrous Oxide / 50% Oxygen Premix During Liver Biopsy of Focal Lesion
A 50% nitrous oxide / 50% oxygen premix is administrated to the patient during the realization of liver biopsy in order to relax him and to reduce his pain during this painful medical trea...
Effect of High Levels of Oxygen and Smoking on the Lungs in Human Volunteers
Patients with lung disease experiencing difficulty breathing can be treated with oxygen therapy. This involves the delivery of "extra" oxygen by a face-mask or through small tubes placed...
Normobaric Oxygen Therapy in Acute Ischemic Stroke Trial
The purpose of this study is to compare the safety and efficacy of treating individuals with acute ischemic stroke with normobaric oxygen therapy (NBO, given within 9 hours of symptom onse...
PubMed Articles
Clinico-therapeutic management of osteoradionecrosis: A literature review and update.
In the management of head and neck cancer, radiotherapy is usually a coadjuvant to surgery, or is applied on a palliative basis. The most important complication of such radiotherapy is osteoradionecro...
Surgical outcome and prognostic factors after treatment of osteoradionecrosis of the jaws.
PURPOSE: This prospective study attempts to identify prognostic factors for outcome in patients Classes 2 and 3 osteoradionecrosis (ORN) treated using individualized methods. METHODS: From 2005 to 201...
PURPOSE: There is still considerable controversy regarding whether hyperbaric oxygen (HBO) therapy used preoperatively and postoperatively will prevent osteoradionecrosis in previously irradiated pati...
Osteoradionecrosis (ORN) is a severe complication of radiation therapy for head and neck cancer. The current theory in its pathophysiology is thought to be radiation-induced fibroatrophy of the bone....
