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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00138827




Registration number
NCT00138827
Ethics application status
Date submitted
29/08/2005
Date registered
30/08/2005
Date last updated
15/12/2005

Titles & IDs
Public title
Mouth Care Regimes During Radiotherapy
Scientific title
A Pilot Randomised Comparison of Bicarbonate Based Mouth Care Versus Biotene Based Mouth Care During Radiotherapy
Secondary ID [1] 0 0
99/65 Graham
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Biotene (mouth care)

Treatment: Drugs: Biotene (mouth care)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mid treatment, 2 and 6 weeks post treatment relative to baseline: Oral comfort - dichotomised as difficulty yes/no based on 3 questions
Timepoint [1] 0 0
Primary outcome [2] 0 0
Mucositis - dichotomised
Timepoint [2] 0 0
Primary outcome [3] 0 0
Xerostomia - dichotomised
Timepoint [3] 0 0
Primary outcome [4] 0 0
Pain medications - dichotomised
Timepoint [4] 0 0
Secondary outcome [1] 0 0
Oral flora
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Oral pH
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Salivary flow
Timepoint [3] 0 0

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- No co-morbidities which may result in dry mouth, for example Sjögren syndrome.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/1999
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St George Hospital, Cancer Care Centre - Sydney
Recruitment postcode(s) [1] 0 0
2217 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
St George Hospital, Australia
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00138827
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Associate Professor Peter H Graham
Address 0 0
St George Hospital, Sydney, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00138827