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

This study has been terminated.
(poor recruitment)
Sponsor:
Collaborator:
Verband Deutscher Druckkammerzentren
Information provided by (Responsible Party):
Thomas Kuhnt, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier:
NCT00682747
First received: May 16, 2008
Last updated: October 26, 2016
Last verified: October 2016
  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: Hyperbaric 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:


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:
  • Number of Adverse Events in all patients as a Measure of Safety and Tolerability [ Time Frame: baseline until 4 weeks after end of study treatment ] [ Designated as safety issue: Yes ]
  • Xerostomia scores assessed by investigator according to Eisbruch et.al. [ Time Frame: baseline compared with measures on day 28, 56 and 146 ] [ Designated as safety issue: No ]
  • Improvement of symptoms/discomfort due to xerestomia assessed by the patient 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 ]

Enrollment: 13
Study Start Date: May 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HBO
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
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: non HBO

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Martin Luther University Halle-Wittenberg, Clinic for Radiotherapy
Halle, Germany, 06120
Druckkammerzentrum Traunstein
Traunstein, Germany, 83278
Sponsors and Collaborators
Thomas Kuhnt
Verband Deutscher Druckkammerzentren
Investigators
Principal Investigator: Thomas Kuhnt, MD University Hospital Rostock, Clinic for Radiotherapy
  More Information

Responsible Party: Thomas Kuhnt, Dr. med., Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT00682747     History of Changes
Other Study ID Numbers: KKSH-037 
Study First Received: May 16, 2008
Last Updated: October 26, 2016
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 December 02, 2016