Status:
TERMINATED
Hyperbaric Oxygen for the Treatment of a Dry Mouth Which Occurred After Radiotherapy
Lead Sponsor:
Thomas Kuhnt
Collaborating Sponsors:
Verband Deutscher Druckkammerzentren
Conditions:
Radiation-induced Xerostomia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether hyperbaric oxygen is effective in the treatment of a dry mouth that occured after radiotherapy for head and neck tumours.
Eligibility Criteria
Inclusion
- complaints of xerostomia (visual analogue scale)
- at least 6 months after radiotherapy of the head and neck region including all salivary glands with at least 50 Gy
- objective hyposalivation / xerostomia (at rest \< 0,25 ml saliva per minute, stimulated \< 0,1 ml saliva per minute)
- patient must have given written informed consent
Exclusion
- prior radiotherapy was an intensity modulated radiotherapy
- prior hyperbaric oxygen therapy after radiotherapy
- conditions which might be an additional risk for the treatment with hyperbaric oxygen such as spontaneous pneumothorax within the last two years, surgery of the eardrum or the middle ear, acute infection of the upper airways, not adequately treated epilepsy, concurrent radio- or chemotherapy, hereditary spherocytosis, psychosis, lung emphysema, asthma, severe COPD, prior surgery of the thorax, pace maker
- myocardial infarction within the last 6 months
- drug therapy which might induce xerostomia
- known intolerance or hypersensitivity to Wrigley's Freident®
- pregnancy or breast-feeding women (for women aged less than 60 years a pregnancy test is mandatory)
- women of childbearing potential with unclear contraception. The following contraceptive methods are recommended: combined oral contraceptives or progesterone-only pill, hormone-dispensing or copper intra-uterine system, hormone patches, long-acting injections, vaginal ring
- treatment with other investigational drugs or participation in another clinical trial within 30 days prior to enrollment
- refusal of cooperation or consent
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00682747
Start Date
May 1 2008
End Date
March 1 2011
Last Update
October 27 2016
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Martin Luther University Halle-Wittenberg, Clinic for Radiotherapy
Halle, Germany, 06120
2
Druckkammerzentrum Traunstein
Traunstein, Germany, 83278