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

Phase 4
18 Years
Not Enrolling
Head and Neck Neoplasms

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Trial Information

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

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

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.

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.

Type of Study:


Study Design:

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

Outcome Measure:

Mid treatment, 2 and 6 weeks post treatment relative to baseline: Oral comfort – dichotomised as difficulty yes/no based on 3 questions

Principal Investigator

Associate Professor Peter H Graham

Investigator Role:

Principal Investigator

Investigator Affiliation:

St George Hospital, Sydney, Australia


Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

99/65 Graham



Start Date:

November 1999

Completion Date:

March 2003

Related Keywords:

  • Head and Neck Neoplasms
  • Radiotherapy
  • Mucositis
  • Xerostomia
  • Neoplasms
  • Head and Neck Neoplasms