Clinical trial NCT00682747: Hyperbaric Oxygen for the Treatment of a Dry Mouth Which Occurred After Radiotherapy
Official title: Randomized Phase II Trial of Hyperbaric Oxygen for the Treatment of Radiation-induced Xerostomia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Radiation-induced Xerostomia
Keywords: xerostomia
hyperbaric oxygenation
radiotherapy
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
Collaborators: name: Verband Deutscher Druckkammerzentren
First posted: 2008-05-22
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: change of overall salivation (millilitre per minute over 5 minutes measured at rest and after provocation) in percentages
timeFrame: baseline compared with measures on day 28, 56 and 146
Secondary outcomes:
measure: Number of Adverse Events in all patients as a Measure of Safety and Tolerability
timeFrame: baseline until 4 weeks after end of study treatment
measure: Xerostomia scores assessed by investigator according to Eisbruch et.al.
timeFrame: baseline compared with measures on day 28, 56 and 146
measure: Improvement of symptoms/discomfort due to xerestomia assessed by the patient on a visual analogue scale
timeFrame: baseline compared with measures on day 28, 56 and 146
measure: quality of life measures (EORTC QLQ-H&N 35)
timeFrame: baseline compared with measures on day 28, 56 and 146
Other outcomes:
Locations:
city: Halle
country: Germany
facility: Martin Luther University Halle-Wittenberg, Clinic for Radiotherapy
city: Traunstein
country: Germany
facility: Druckkammerzentrum Traunstein
Study officials:
affiliation: University Hospital Rostock, Clinic for Radiotherapy
name: Thomas Kuhnt, MD
role: PRINCIPAL_INVESTIGATOR
References: