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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Martin-Luther-Universität Halle-Wittenberg.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Verband Deutscher Druckkammerzentren (VDD e.V.)
Information provided by:
Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier:
NCT00682747
First received: May 16, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Hyperbaric Oxygen for the Treatment of Radiation-Induced Xerostomia

Resource links provided by NLM:

U.S. FDA Resources

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
Experimental: 1 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)
No Intervention: 2

  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: Dr. med. Thomas Kuhnt, Martin Luther University Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT00682747     History of Changes
Other Study ID Numbers: KKSH-037
Study First Received: May 16, 2008
Last Updated: May 16, 2008
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:
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 22, 2013