Mouth Care Regimes During Radiotherapy

Head and Neck Neoplasms Clinical Trial

Official title:

A Pilot Randomised Comparison of Bicarbonate Based Mouth Care Versus Biotene Based Mouth Care During Radiotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00138827
• Other study ID #: 99/65 Graham
• Status: Completed
• Phase: Phase 4
• First received: August 29, 2005
• Last updated: December 14, 2005
• Start date: November 1999
• Est. completion date: March 2003

Study information

• Verified date: May 1998
• Source: St George Hospital, Australia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

Drug:
• Biotene (mouth care)

Locations

Country	Name	City	State
Australia	St George Hospital, Cancer Care Centre	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
St George Hospital, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mid treatment, 2 and 6 weeks post treatment relative to baseline: Oral comfort – dichotomised as difficulty yes/no based on 3 questions
Primary	Mucositis – dichotomised
Primary	Xerostomia – dichotomised
Primary	Pain medications – dichotomised
Secondary	Oral flora
Secondary	Oral pH
Secondary	Salivary flow