Status:
COMPLETED
Mouth Care Regimes During Radiotherapy
Lead Sponsor:
St George Hospital, Australia
Conditions:
Head and Neck Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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.
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 nutritio...
Eligibility Criteria
Inclusion
- 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
- No co-morbidities which may result in dry mouth, for example Sjögren syndrome.
Key Trial Info
Start Date :
November 1 1999
Trial Type :
INTERVENTIONAL
End Date :
March 1 2003
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00138827
Start Date
November 1 1999
End Date
March 1 2003
Last Update
December 15 2005
Active Locations (1)
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1
St George Hospital, Cancer Care Centre
Sydney, New South Wales, Australia, 2217