Hyperbaric Oxygen - a New Treatment Modality in Patients With Radiation Damaged Salivary Gland Tissue

Phase 3

• Conditions: Late Effect of Radiation

• Registration Number: NCT01606644
• Lead Sponsor: Lone Forner

Brief Summary

Randomized clinical trial regarding the effect of hyperbaric oxygen on late radiation tissue injury to salivary gland tissue.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-06
• Status Verified: 2012-05
• Study First Submitted QC: 2012-05-25
• Last Update Submitted: 2012-05-25
• Study First Posted: 2012-05-28
• Last Update Posted: 2012-05-28
• Primary Completion: 2014-04
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

• Surgical treatment of head and neck cancer
• Salivary gland disease
• Severe claustrophobia
• Pregnancy or lactation (fertile women must use safe contraceptives)
• Uncontrolled hypertension (> 220/110)
• Epilepsy
• Lack of ability to equalize inner ear pressure
• Pneumothorax
• Thoracic surgery within one month before HBO treatment
• Abuse of alcohol, drugs or narcotics
• Exposed titanium surfaces or defect titanium in the oral cavity
• Previous HBO treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Salivation rate	6 months

Secondary Outcome Measures

Name	Time	Method
Quality of life	6 months
Xerostomia	6 months	Xerostomia questionnaire

Trial Locations

Locations (1)

Department of Anaesthesia and Department of Oral and Maxillofacial Surgery, Copenhagen University Hospital; 🇩🇰 Copenhagen, Denmark