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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
40 treatments with hyperbaric oxygen once per day, five days per week, 2.4 ATA, 100 % oxygen (10-15 minutes compression with air, 90 min of oxygen breathing - two 10 minutes break for breathing air after each 30 minutes of oxygen, 10 minutes decompression with oxygen
Martin Luther University Halle-Wittenberg, Clinic for Radiotherapy
Halle, Germany
Druckkammerzentrum Traunstein
Traunstein, Germany
change of overall salivation (millilitre per minute over 5 minutes measured at rest and after provocation) in percentages
Time frame: baseline compared with measures on day 28, 56 and 146
Number of Adverse Events in all patients as a Measure of Safety and Tolerability
Time frame: baseline until 4 weeks after end of study treatment
Xerostomia scores assessed by investigator according to Eisbruch et.al.
Time frame: baseline compared with measures on day 28, 56 and 146
Improvement of symptoms/discomfort due to xerestomia assessed by the patient on a visual analogue scale
Time frame: baseline compared with measures on day 28, 56 and 146
quality of life measures (EORTC QLQ-H&N 35)
Time frame: baseline compared with measures on day 28, 56 and 146
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