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临床试验/NCT00138827
NCT00138827已完成4 期

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

St George Hospital, Australia2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 1999年11月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
Mid treatment, 2 and 6 weeks post treatment relative to baseline: Oral comfort - dichotomised as difficulty yes/no based on 3 questions

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • No co-morbidities which may result in dry mouth, for example Sjögren syndrome.

结局指标

主要结局

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

次要结局

  • Oral flora
  • Oral pH
  • Salivary flow

研究者

发起方
St George Hospital, Australia
申办方类型
Other

研究点 (2)

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