Hyperbaric Oxygen for the Treatment of a Dry Mouth Which Occurred After Radiotherapy
October 26, 2016 updated by: Thomas Kuhnt
Randomized Phase II Trial of Hyperbaric Oxygen for the Treatment of Radiation-induced Xerostomia
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Halle, Germany, 06120
- Martin Luther University Halle-Wittenberg, Clinic for Radiotherapy
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Traunstein, Germany, 83278
- Druckkammerzentrum Traunstein
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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)
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
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baseline compared with measures on day 28, 56 and 146
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
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baseline until 4 weeks after end of study treatment
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Xerostomia scores assessed by investigator according to Eisbruch et.al.
Time Frame: baseline compared with measures on day 28, 56 and 146
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baseline compared with measures on day 28, 56 and 146
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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
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baseline compared with measures on day 28, 56 and 146
|
|
quality of life measures (EORTC QLQ-H&N 35)
Time Frame: baseline compared with measures on day 28, 56 and 146
|
baseline compared with measures on day 28, 56 and 146
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas Kuhnt, MD, University Hospital Rostock, Clinic for Radiotherapy
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (ACTUAL)
March 1, 2011
Study Completion (ACTUAL)
March 1, 2011
Study Registration Dates
First Submitted
May 16, 2008
First Submitted That Met QC Criteria
May 16, 2008
First Posted (ESTIMATE)
May 22, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
October 27, 2016
Last Update Submitted That Met QC Criteria
October 26, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KKSH-037
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.