| May 16, 2008 |
| May 16, 2008 |
| May 2008 |
| October 2009 (final data collection date for primary outcome measure) |
| 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 ] [ Designated as safety issue: No ] |
| Same as current |
| No Changes Posted |
- toxicity [ Time Frame: during participation in the trial ] [ Designated as safety issue: Yes ]
- xerostomia scores [ Time Frame: baseline compared with measures on day 28, 56 and 146 ] [ Designated as safety issue: No ]
- improvement of symptoms measured on a visual analogue scale [ Time Frame: baseline compared with measures on day 28, 56 and 146 ] [ Designated as safety issue: No ]
- quality of life measures (EORTC QLQ-H&N 35) [ Time Frame: baseline compared with measures on day 28, 56 and 146 ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| Hyperbaric Oxygen for the Treatment of a Dry Mouth Which Occurred After Radiotherapy |
| Randomized Phase II Trial of Hyperbaric Oxygen for the Treatment of Radiation-Induced Xerostomia |
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. |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
| Radiation-Induced Xerostomia |
| Drug: oxygen |
| |
| |
| |
| Recruiting |
| 100 |
| October 2009 |
| October 2009 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years to 75 Years |
| No |
|
|
| Germany |
| |
| NCT00682747 |
| Dr. med. Thomas Kuhnt, Martin Luther University Halle-Wittenberg |
| KKSH-037 |
| Martin-Luther-Universität Halle-Wittenberg |
| Verband Deutscher Druckkammerzentren (VDD e.V.) |
| Principal Investigator: |
Thomas Kuhnt, MD |
Martin Luther University Halle-Wittenberg, Clinic for Radiotherapy |
|
|
| Martin-Luther-Universität Halle-Wittenberg |
| May 2008 |
