Head and Neck NeoplasmsPhase 4NCT00138827
Mouth Care Regimes During Radiotherapy
A Phase 4 study testing Biotene (mouth care) in people with Head and Neck Neoplasms, run by St George Hospital, Australia at 1 site in Australia.
Trial summary
The purpose of this study is to assess whether Biotene oral care products have a benefit in the treatment of xerostomia and mucositis when compared with conventional bicarbonate mouth care regimes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Biotene (mouth care)
- How many people
- 50 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 1999to Mar 2003
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are undergoing oral or pharyngeal irradiation with a cumulative dose > 35Gy with at least 1/2 of the salivary tissue contained within the field of treatment.
- May or may not have undergone surgery.
- Are available for follow-up questionnaires.
- Are English speaking or have an easily accessible interpreter.
Who cannot join
- No co-morbidities which may result in dry mouth, for example Sjögren syndrome.
Trial locations and contacts
1 site in 1 country.
Australia1 site
St George Hospital, Cancer Care Centre
Sydney, New South Wales, 2217
About this study
Official title: A Pilot Randomised Comparison of Bicarbonate Based Mouth Care Versus Biotene Based Mouth Care During Radiotherapy
The purpose of this study is to assess whether Biotene oral care products have a benefit in the treatment of xerostomia and mucositis when compared with conventional bicarbonate mouth care regimes.
Read the detailed description
Grade III and IV mucositis occurs in 30-60% of patients undergoing head and neck irradiation. Where mucositis is severe a patient's ability to swallow may become significantly compromised and nutritional requirements may not be met.
Xerostomia is often an early side effect of treatment. As salivary tissue is very sensitive to radiation there is often a change in saliva early in the treatment.
New products on the market have claimed to alleviate the symptoms of dry mouth and to help the body's natural defenses reduce the harmful oral bacteria. These products contain the important salivary enzymes lactoperoxidase, lysozyme, lactoferrin and glucose oxidase. Biotene products therefore have the potential to reduce microbial populations which result in radiation caries and periodontal disease and in addition provide relief from the discomfort of xerostomia.
Despite the knowledge surrounding xerostomia in the head and neck irradiation population, its treatment has not been well documented and the question of patient comfort is not well addressed.
Comparisons: This study aims to compare the different mouth care regimes and determine the most effective treatment alternatives during radiotherapy. Patients will be randomised to either Biotene or Bicarbonate-based mouth care regimes. Patients will be stratified according to whether they are receiving radiotherapy alone or chemo irradiation to ensure equal distribution across the different mouth care regimes.
- Conditions
- Head and Neck Neoplasms
- Being tested
- Biotene (mouth care)
- Keywords
- Radiotherapy, Mucositis, Xerostomia
- Medical subject headings
- Head and Neck Neoplasms, Mucositis, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biotene (mouth care)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Mid treatment, 2 and 6 weeks post treatment relative to baseline: Oral comfort - dichotomised as difficulty yes/no based on 3 questions
Mucositis - dichotomised
Xerostomia - dichotomised
Pain medications - dichotomised
Secondary outcomes (3)
Oral flora
Oral pH
Salivary flow
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startNov 1999
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- St George Hospital, Australia
- Sponsor type
- University, hospital or other
- Investigators
- Associate Professor Peter H Graham, Principal investigator, St George Hospital, Sydney, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138827
- Sponsor's protocol ID
- 99/65 Graham
- Status last verified
- May 1998
- First submitted
- 29 Aug 2005
- Last updated
- 15 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomised Comparison of Bicarbonate Based Mouth Care Versus Biotene Based Mouth Care During Radiotherapy
- ClinicalTrials.gov ID
- NCT00138827
- Acronym / sponsor ID
- 99/65 Graham
- Conditions
- Head and Neck Neoplasms
- Keywords
- Radiotherapy, Mucositis, Xerostomia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- St George Hospital, AustraliaUniversity, hospital or other
- Study start
- Nov 1999
- Study completion
- Mar 2003
- First posted
- 30 Aug 2005 (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 assess whether Biotene oral care products have a benefit in the treatment of xerostomia and mucositis when compared with conventional bicarbonate mouth care regimes.
Detailed description
Grade III and IV mucositis occurs in 30-60% of patients undergoing head and neck irradiation. Where mucositis is severe a patient's ability to swallow may become significantly compromised and nutritional requirements may not be met.
Xerostomia is often an early side effect of treatment. As salivary tissue is very sensitive to radiation there is often a change in saliva early in the treatment.
New products on the market have claimed to alleviate the symptoms of dry mouth and to help the body's natural defenses reduce the harmful oral bacteria. These products contain the important salivary enzymes lactoperoxidase, lysozyme, lactoferrin and glucose oxidase. Biotene products therefore have the potential to reduce microbial populations which result in radiation caries and periodontal disease and in addition provide relief from the discomfort of xerostomia.
Despite the knowledge surrounding xerostomia in the head and neck irradiation population, its treatment has not been well documented and the question of patient comfort is not well addressed.
Comparisons: This study aims to compare the different mouth care regimes and determine the most effective treatment alternatives during radiotherapy. Patients will be randomised to either Biotene or Bicarbonate-based mouth care regimes. Patients will be stratified according to whether they are receiving radiotherapy alone or chemo irradiation to ensure equal distribution across the different mouth care regimes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are undergoing oral or pharyngeal irradiation with a cumulative dose > 35Gy with at least 1/2 of the salivary tissue contained within the field of treatment.
- May or may not have undergone surgery.
- Are available for follow-up questionnaires.
- Are English speaking or have an easily accessible interpreter.
Key exclusion criteria (1 listed)
- No co-morbidities which may result in dry mouth, for example Sjögren syndrome.
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 |
|---|---|---|
| Biotene (mouth care) | Drug | – |
Primary outcome
Mid treatment, 2 and 6 weeks post treatment relative to baseline: Oral comfort - dichotomised as difficulty yes/no based on 3 questions
Mucositis - dichotomised
Xerostomia - dichotomised
Pain medications - dichotomised
3 secondary outcomes
Oral flora
Oral pH
Salivary flow
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2005.
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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.
Associate Professor Peter H Graham principal investigator
St George Hospital, Sydney, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Biotene (mouth care) in people with Head and Neck Neoplasms, run by St George Hospital, Australia at 1 site in Australia.
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 1 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: finished, as of the sponsor's last update on 15 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mid treatment, 2 and 6 weeks post treatment relative to baseline: Oral comfort - dichotomised as difficulty yes/no based on 3 questions. The study lists 4 primary outcomes in all. 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 15 Dec 2005.