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

NCT00138827 Phase 4 COMPLETED

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.

Details

Lead sponsor	St George Hospital, Australia
Phase	Phase 4
Status	COMPLETED
Enrolment	50
Start date	1999-11
Completion	2003-03

Conditions

• Head and Neck Neoplasms

Interventions

• Biotene (mouth care)

Primary outcomes

• 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

Countries

Australia