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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01606644
Other study ID # HBO Copenhagen study
Secondary ID
Status Recruiting
Phase Phase 3
First received May 6, 2010
Last updated May 25, 2012
Start date May 2010
Est. completion date April 2014

Study information

Verified date May 2012
Source Rigshospitalet, Denmark
Contact Lone Forner, DDS, PhD
Phone +45 3545 8211
Email lone.forner@rh.regionh.dk
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial Summary

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


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Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Procedure:
Hyperbaric oxygen
Inhalation of 100% oxygen for 90 minutes

Locations

Country Name City State
Denmark Department of Anaesthesia and Department of Oral and Maxillofacial Surgery, Copenhagen University Hospital Copenhagen

Sponsors (2)

Lead Sponsor Collaborator
Lone Forner Danish Cancer Society

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Salivation rate 6 months No
Secondary Quality of life 6 months No
Secondary Xerostomia Xerostomia questionnaire 6 months No
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