Hyperbaric Oxygen - a new treatment modality in patients with salivary gland radiation injury

Conditions: ate radiation tissue injury to salivary glands
MedDRA version: 12.0Level: LLTClassification code 10013781Term: Dry mouth

Registration Number: EUCTR2009-016668-35-DK

Lead Sponsor: Copenhagen University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Head and neck cancer with planned radiation therapy
Age >18 years 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

Surgical treatment of head and neck cancer, previous or current
Salivary gland diseases
Active cancer at the time of HBO treatment
Severe claustrophobia
Pregnancy or lactation
Uncontrolled hypertension
Epilepsy
Lack of ability to equalize pressure in the inner ear
Pneumothorax
Thoracic surgery within one month of HBO treatment
Abuse of alcohol, medication or narcotics
Exposed titanium reconstructive parts or defect titanium implant surface·Previous HBO treatment

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 on radiation salivary gland injury;Secondary Objective: Life quality ;Primary end point(s): Daily sensation of oral dryness <br>Unstimulated whole saliva flow rate (ml/min)<br>Stimulated (paraffin-chewing) whole saliva flow rate (ml/min)<br>Stimulated (0.5% citric acid) parotid saliva flow rate (ml/min)<br>Impact of oral health on quality of life<br>

Secondary Outcome Measures