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

Phase 2

Terminated

• Conditions: Radiation-induced Xerostomia
• Interventions: Drug: Hyperbaric oxygen

• Registration Number: NCT00682747
• Lead Sponsor: Thomas Kuhnt

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-16
• Study First Submitted QC: 2008-05-16
• Study First Posted: 2008-05-22
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HBO	Hyperbaric 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)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
quality of life measures (EORTC QLQ-H&N 35)	baseline compared with measures on day 28, 56 and 146

Trial Locations

Locations (2)

Druckkammerzentrum Traunstein; 🇩🇪 Traunstein, Germany

Martin Luther University Halle-Wittenberg, Clinic for Radiotherapy; 🇩🇪 Halle, Germany