Hyperbaric Oxygen - a New Treatment Modality in Patients With Radiation Damaged Salivary Gland Tissue.
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Late Effect of Radiation
Both
Late Effect of Radiation
Trial Information
Hyperbaric Oxygen - a New Treatment Modality in Patients With Radiation Damaged Salivary Gland Tissue.
Inclusion Criteria
Inclusion Criteria
- Head and neck cancer with planned radiation therapy
- Age > 18 years
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Salivation rate
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Lone Forner, DDS, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Copenhagen University Hospital
Authority:
Denmark: Danish Medicines Agency
Study ID:
HBO Copenhagen study
NCT ID:
NCT01606644
Start Date:
May 2010
Completion Date:
April 2014
Related Keywords:
- Late Effect of Radiation
- radiation sequelae
- hyperbaric oxygen
- Radiation Injuries
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