Radiation-induced XerostomiaPhase 2NCT00682747
Hyperbaric Oxygen for the Treatment of a Dry Mouth Which Occurred After Radiotherapy
A Phase 2 study testing Hyperbaric oxygen in people with Radiation-induced Xerostomia, run by Thomas Kuhnt at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Radiation-induced Xerostomia
- What is being tested?
- Hyperbaric oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesGermany
- Study dates
- May 2008to Mar 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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®
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- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Martin Luther University Halle-Wittenberg, Clinic for Radiotherapy
Halle, 06120
Druckkammerzentrum Traunstein
Traunstein, 83278
About this study
Official title: 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.
- Conditions
- Radiation-induced Xerostomia
- Being tested
- Hyperbaric oxygen
- Keywords
- xerostomia, hyperbaric oxygenation, radiotherapy
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygenDrug
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
| Study group | Role | What they receive |
|---|---|---|
| HBO | Experimental | 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) Receives: Drug: Hyperbaric oxygen |
| non HBO | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of overall salivation (millilitre per minute over 5 minutes measured at rest and after provocation) in percentages
Measured: baseline compared with measures on day 28, 56 and 146
Secondary outcomes (4)
Number of Adverse Events in all patients as a Measure of Safety and Tolerability
Measured: baseline until 4 weeks after end of study treatment
Xerostomia scores assessed by investigator according to Eisbruch et.al.
Measured: baseline compared with measures on day 28, 56 and 146
Improvement of symptoms/discomfort due to xerestomia assessed by the patient on a visual analogue scale
Measured: baseline compared with measures on day 28, 56 and 146
quality of life measures (EORTC QLQ-H&N 35)
Measured: baseline compared with measures on day 28, 56 and 146
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2008 (estimated)
- Study startMay 2008
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation-induced XerostomiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Kuhnt
- Sponsor type
- University, hospital or other
- Collaborators
- Verband Deutscher Druckkammerzentren
- Responsible party
- Sponsor-investigator, Thomas Kuhnt, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Thomas Kuhnt, MD, Principal investigator, University Hospital Rostock, Clinic for Radiotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682747
- Sponsor's protocol ID
- KKSH-037
- Status last verified
- Oct 2016
- First submitted
- 16 May 2008
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial of Hyperbaric Oxygen for the Treatment of Radiation-induced Xerostomia
- ClinicalTrials.gov ID
- NCT00682747
- Acronym / sponsor ID
- KKSH-037
- Conditions
- Radiation-induced Xerostomia
- Keywords
- xerostomia, hyperbaric oxygenation, radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor recruitment
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Thomas KuhntUniversity, hospital or other
- Collaborators
- Verband Deutscher Druckkammerzentren
- Study start
- May 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 22 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HBO | Experimental | Drug: Hyperbaric oxygen40 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) |
| non HBO | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric oxygen40 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 | HBO |
Primary outcome
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
4 secondary outcomes
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
Xerostomia scores assessed by investigator according to Eisbruch et.al.
Time frame: baseline compared with measures on day 28, 56 and 146
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
quality of life measures (EORTC QLQ-H&N 35)
Time frame: baseline compared with measures on day 28, 56 and 146
Results and safety
The study was stopped early (reason given: poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Kuhnt, MD principal investigator
University Hospital Rostock, Clinic for Radiotherapy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyperbaric oxygen in people with Radiation-induced Xerostomia, run by Thomas Kuhnt at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: poor recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2016.