Mouth Care Regimes During Radiotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00138827
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : December 15, 2005
Information provided by:
St George Hospital, Australia

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.

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Drug: Biotene (mouth care) Phase 4

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 Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: A Pilot Randomised Comparison of Bicarbonate Based Mouth Care Versus Biotene Based Mouth Care During Radiotherapy
Study Start Date : November 1999
Study Completion Date : March 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Primary Outcome Measures :
  1. Mid treatment, 2 and 6 weeks post treatment relative to baseline: Oral comfort – dichotomised as difficulty yes/no based on 3 questions
  2. Mucositis – dichotomised
  3. Xerostomia – dichotomised
  4. Pain medications – dichotomised

Secondary Outcome Measures :
  1. Oral flora
  2. Oral pH
  3. Salivary flow

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00138827

Australia, New South Wales
St George Hospital, Cancer Care Centre
Sydney, New South Wales, Australia, 2217
Sponsors and Collaborators
St George Hospital, Australia
Principal Investigator: Associate Professor Peter H Graham St George Hospital, Sydney, Australia Identifier: NCT00138827     History of Changes
Other Study ID Numbers: 99/65 Graham
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: December 15, 2005
Last Verified: May 1998

Keywords provided by St George Hospital, Australia:

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site