Late radiation tissue injury to salivary glands MedDRA version: 12.0 Level: LLT Classification code 10013781 Term: Dry mouth
Conditions
Interventions
Trade Name: Medicinsk Luft "AGA"
Product Name: Medicinsk Luft "AGA"
Pharmaceutical Form: Inhalation gas
CAS Number: 7782-44-7
Other descriptive name: OXYGEN
Concentration unit: % percent
Concentratio
Sponsors
Copenhagen University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Unstimulated whole saliva flow rate (ml/min) Stimulated (paraffin-chewing) whole saliva flow rate (ml/min) Stimulated (0.5% citric acid) parotid saliva flow rate (ml/min) Impact of oral health on quality of life | — |
Countries
Denmark
Outcome results
None listed