Hyperbaric Oxygen - a New Treatment Modality in Patients With Radiation Damaged Salivary Gland Tissue
NCT ID: NCT01606644
Last Updated: 2012-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
60 participants
INTERVENTIONAL
2010-05-31
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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HBO
30 90-minute hyperbaric oxygen sessions at 2.4 atm.
Hyperbaric oxygen
Inhalation of 100% oxygen for 90 minutes
No HBO
No intervention. No hyperbaric oxygen is administered. Otherwise, the patient will follow the examination program.
No interventions assigned to this group
Interventions
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Hyperbaric oxygen
Inhalation of 100% oxygen for 90 minutes
Eligibility Criteria
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Inclusion Criteria
* Age \> 18 years
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Danish Cancer Society
OTHER
Lone Forner
OTHER
Responsible Party
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Lone Forner
DDS, PhD
Principal Investigators
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Lone Forner, DDS, PhD
Role: PRINCIPAL_INVESTIGATOR
Copenhagen University Hospital at Herlev
Locations
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Department of Anaesthesia and Department of Oral and Maxillofacial Surgery, Copenhagen University Hospital
Copenhagen, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HBO Copenhagen study
Identifier Type: -
Identifier Source: org_study_id
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