Hyperbaric Oxygen for the Treatment of a Dry Mouth Which Occurred After Radiotherapy

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Phase II Trial of Hyperbaric Oxygen for the Treatment of Radiation-induced Xerostomia

Conditions
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Radiation-induced Xerostomia

Intervention / Treatment
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* Drug: Hyperbaric oxygen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HBO<br>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) | Drug: Hyperbaric oxygen<br>* 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<br>|
| No Intervention: non HBO<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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xerostomia, hyperbaric oxygenation, radiotherapy