Mouth Care Regimes During Radiotherapy

This study has been completed.
Sponsor:
Information provided by:
St George Hospital, Australia
ClinicalTrials.gov Identifier:
NCT00138827
First received: August 29, 2005
Last updated: December 14, 2005
Last verified: May 1998
  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

Resource links provided by NLM:


Further study details as provided by St George Hospital, Australia:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • Oral flora
  • Oral pH
  • Salivary flow

Estimated Enrollment: 50
Study Start Date: November 1999
Estimated Study Completion Date: March 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00138827

Locations
Australia, New South Wales
St George Hospital, Cancer Care Centre
Sydney, New South Wales, Australia, 2217
Sponsors and Collaborators
St George Hospital, Australia
Investigators
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 July 28, 2014