Mouth Care Regimes During Radiotherapy
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Neoplasms |
Drug: Biotene (mouth care) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | A Pilot Randomised Comparison of Bicarbonate Based Mouth Care Versus Biotene Based Mouth Care During Radiotherapy |
- 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
- Oral flora
- Oral pH
- Salivary flow
| Estimated Enrollment: | 50 |
| Study Start Date: | November 1999 |
| Estimated Study Completion Date: | March 2003 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- No co-morbidities which may result in dry mouth, for example Sjögren syndrome.
Contacts and Locations| Australia, New South Wales | |
| St George Hospital, Cancer Care Centre | |
| Sydney, New South Wales, Australia, 2217 | |
| Principal Investigator: | Associate Professor Peter H Graham | St George Hospital, Sydney, Australia |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00138827 History of Changes |
| Other Study ID Numbers: | 99/65 Graham |
| Study First Received: | August 29, 2005 |
| Last Updated: | December 14, 2005 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by St George Hospital, Australia:
|
Radiotherapy Mucositis Xerostomia |
Additional relevant MeSH terms:
|
Neoplasms Head and Neck Neoplasms Neoplasms by Site |
ClinicalTrials.gov processed this record on May 16, 2013