Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00138827
Status:
COMPLETED
Last Update Posted:
2005-12-15
First Post:
2005-08-29
Brief Title:
Mouth Care Regimes During Radiotherapy
Sponsor:
St George Hospital Australia
Organization:
St George Hospital Australia
Study Overview
Official Title:
A Pilot Randomised Comparison of Bicarbonate Based Mouth Care Versus Biotene Based Mouth Care During Radiotherapy
Status:
COMPLETED
Status Verified Date:
1998-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Grade III and IV mucositis occurs in 30-60 of patients undergoing head and neck irradiation Where mucositis is severe a patients 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 bodys 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
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 bodys 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None