Hyperbaric oxygen treatment of radiotherapy injury to the jaw.

Phase 1

• Conditions: Mandibular osteoradionecrosis occuring from radiation treatment of cancer.No healthy volunteers; MedDRA version: 19.0Level: PTClassification code 10064658Term: Osteonecrosis of jawSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]

• Registration Number: EUCTR2007-007842-36-DK
• Lead Sponsor: one Elisabeth Forner

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-04-21
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

1. Osteoradionecrosis grade 2, 3 or 4 (CTCAE v 3.0.)
2. Localization: Mandibula
3. Age over 18 yrs old

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Malignant diseases that may affect the course of the treatment or disease
2.Previous HBO treatment for osteoradionecrosis
3.Pregnancy
4.Uncontrolled hypertension
5.Lack of ability to equalize the pressure in the the ears and sinuses, although incision or drain of the tympanic membrane is an accepted adjunctive measure
6.Claustrophobia
7.Pneumothorax

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of hyperbaric oxygen treatment on mandibular osteoradionecrosis.;Secondary Objective: To evaluate effect of hyperbaric oxygen treatment on life quality in osteoradionecrosis patients.;Primary end point(s): The primary endpoint recovery from osteoradionecrosis as defined by the NCI Common Toxicity Criteria of Adverse Events (CTCAE) v 3.0. Recovery is defined as no signs of osteoradionecrosis according to these criteria or grade 1 on this scale. <br><br>Grade 0: No signs of disease<br>Grade 1: Asymptomatic, radiographic findings only. <br>Grade 2: Symptomatic and interfering with function, but not interfering with ADL (Activities of Daily Living). Minimal bone removal indicated i.e. minor sequestrectomy). <br>Grade 3: Symptomatic, interfering with ADL. Operative intervention or hyperbaric oxygen indicated. <br>Grade 4: Disabling <br>Grade 5: Death<br>;Timepoint(s) of evaluation of this end point: 1 week, 1 month, 3 months and 12 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Quality of life ;Timepoint(s) of evaluation of this end point: 1 week, 1 month, 3 months and 12 months