Radiation-induced Xerostomia
Conditions
Keywords
xerostomia, hyperbaric oxygenation, radiotherapy
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.
Interventions
DRUGHyperbaric oxygen
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
Sponsors
Verband Deutscher Druckkammerzentren
Thomas Kuhnt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change of overall salivation (millilitre per minute over 5 minutes measured at rest and after provocation) in percentages | baseline compared with measures on day 28, 56 and 146 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Adverse Events in all patients as a Measure of Safety and Tolerability | baseline until 4 weeks after end of study treatment |
| Xerostomia scores assessed by investigator according to Eisbruch et.al. | 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 | baseline compared with measures on day 28, 56 and 146 |
| quality of life measures (EORTC QLQ-H&N 35) | baseline compared with measures on day 28, 56 and 146 |
Countries
Germany
Outcome results
None listed