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

This study is currently recruiting participants.

Verified by Martin-Luther-Universität Halle-Wittenberg, May 2008

First Received: May 16, 2008 No Changes Posted

Sponsor:	Martin-Luther-Universität Halle-Wittenberg
Collaborator:	Verband Deutscher Druckkammerzentren (VDD e.V.)
Information provided by:	Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier:	NCT00682747

Purpose

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.

Condition	Intervention	Phase
Radiation-Induced Xerostomia	Drug: oxygen	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Randomized Phase II Trial of Hyperbaric Oxygen for the Treatment of Radiation-Induced Xerostomia

Further study details as provided by Martin-Luther-Universität Halle-Wittenberg:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	100
Study Start Date:	May 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: 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)
2: No Intervention

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682747

Contacts

Contact: Thomas Kuhnt, MD

++49 345 557 7205

thomas.kuhnt@medizin.uni-halle.de

Locations

Germany
Martin Luther University Halle-Wittenberg, Clinic for Radiotherapy	Recruiting
Halle, Germany, 06120
Contact: Thomas Kuhnt, MD ++49 345 557 7205 thomas.kuhnt@medizin.uni-halle.de
Principal Investigator: Thomas Kuhnt, MD
Druckkammerzentrum Traunstein	Recruiting
Traunstein, Germany, 83278
Contact: Christian Heiden, MD ++49 861 15967
Principal Investigator: Christian Heiden, MD

Sponsors and Collaborators

Martin-Luther-Universität Halle-Wittenberg

Verband Deutscher Druckkammerzentren (VDD e.V.)

Investigators

Principal Investigator:

Thomas Kuhnt, MD

Martin Luther University Halle-Wittenberg, Clinic for Radiotherapy

More Information

No publications provided

Responsible Party:	Martin Luther University Halle-Wittenberg ( Dr. med. Thomas Kuhnt )
Study ID Numbers:	KKSH-037
Study First Received:	May 16, 2008
Last Updated:	May 16, 2008
ClinicalTrials.gov Identifier:	NCT00682747 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Martin-Luther-Universität Halle-Wittenberg:

xerostomia
hyperbaric oxygenation
radiotherapy

Additional relevant MeSH terms:

Mouth Diseases
Stomatognathic Diseases
Salivary Gland Diseases
Xerostomia

ClinicalTrials.gov processed this record on November 25, 2009