A study looking at a treatment to prevent jaw bone damage in head and neck cancer

Phase 1

• Conditions: Osteoradionecrosis (ORN) of the irradiated mandible; the most feared complication of radiotherapy for head and neck cancer.; MedDRA version: 19.1 Level: PT Classification code 10064658 Term: Osteonecrosis of jaw System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]

• Registration Number: EUCTR2007-006225-27-GB
• Lead Sponsor: The University of Liverpool

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-26
• Study Completion: 2018-01-24
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 144

Inclusion Criteria

1.Age > 18 years
2.Prior history of external beam radiotherapy (dose > 50Gy) to mandible or prior history of brachytherapy with equivalent radiation dose as above.
3.No evidence of cancer recurrence
4.New diagnosis of condition requiring surgery to mandible (commonest examples but not limited to: dental extraction, implant placement, surgical tooth, cyst or osteosynthesis plate removal)
5.Patient has read and understood information leaflet and is willing to be randomised.
6.Patient competent to consent and psychologically / physically fit for HBO.

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 221
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 221

Exclusion Criteria

1.Known contraindications to HBO:
a.Lung disease: Chronic obstructive airways disease; bullous lung disease, acute or chronic pulmonary infection; uncontrolled asthma, untreated pneumothorax
b.Middle ear disease; previous middle ear operations, eustachian tube dysfunction or recurrent attacks of vertigo
2.Prior hyperbaric oxygen therapy
3.Prior diagnosis of osteoradionecrosis of the mandible
4.Previous surgery for osteoradionecrosis
5.Any history of systemic bisphosphonate therapy, pentoxyphylline or tocopherol.
6.Pregnancy

Study & Design

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