Trial registered on ANZCTR


Trial ID
ACTRN12605000057684
Ethics application status
Approved
Date submitted
22/07/2005
Date registered
1/08/2005
Date last updated
1/08/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
A double blind pilot study testing the effectiveness of Biotene mouthwash versus Normal Saline mouthwash to reduce the symptoms associated with mucositis in high dose chemotherapy patients.
Scientific title
A double blind pilot study testing the effectiveness of Biotene mouthwash versus Normal Saline mouthwash to reduce the symptoms associated with mucositis in high dose chemotherapy patients.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral Mucositis 128 0
Condition category
Condition code
Oral and Gastrointestinal 146 146 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 147 147 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Biotene mouthwash 20mls four times a day for the period of 21 days
Intervention code [1] 50 0
Treatment: Other
Comparator / control treatment
Normal Saline mouthwash 20mls four times a day for the period of 21 days.
Control group
Active

Outcomes
Primary outcome [1] 184 0
Oral mucositis related symptoms
Timepoint [1] 184 0
Measured on the first day of chemotherapy and then alternate days until the end of the study at 21 days
Secondary outcome [1] 411 0
Level and severity of mucositis
Timepoint [1] 411 0
Measured on the first day of chemotherapy and then alternate days until the end of the study at 21 days.
Secondary outcome [2] 412 0
Compliance with oral care regime
Timepoint [2] 412 0
Measured on the first day of chemotherapy and then alternate days until the end of the study at 21 days.

Eligibility
Key inclusion criteria
1. Diagnosed with acute leukaemia, high grade lymphoma, or any other disease that requires high dose chemotherapy and patients receiving an autogenic stem cell transplant 2. In patient of the study hospital and over the age of 18 years 3. Able to read and understand English 4. Agrees to use no other mouthwashes at time of inclusion into study 5. Agrees to participate in an RCT.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients receiving radiation treatment to head or neck 2. Patients who have a psychiatric history or mental/physical impairment that would hinder the individual to comply with the intervention.

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)
The pharmacist who will package and distribute the mouthwashes will place a coded number on identical bottles. The researchers and those directly caring for the patient will not be aware of the allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number sequence- no restriction
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
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)

Funding & Sponsors
Funding source category [1] 200 0
Government body
Name [1] 200 0
Queensland Nursing Council
Address [1] 200 0
Country [1] 200 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Auspharm Australia
Address
Country
Australia
Secondary sponsor category [1] 149 0
Hospital
Name [1] 149 0
Mater Health Services
Address [1] 149 0
Country [1] 149 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 961 0
Mater Health Services
Ethics committee address [1] 961 0
Ethics committee country [1] 961 0
Australia
Date submitted for ethics approval [1] 961 0
Approval date [1] 961 0
Ethics approval number [1] 961 0

Summary
Brief summary
One of the most painful and debilitating side effects of chemotherapy is mucoisits. Oral mucositis involves swelling, irritation, and ulceration of the lining of the mouth. Good mouth care including mouthwashes has been shown to relieve symptoms. Currently, there is no strong evidence to support the use of any mouthwash. This is a pilot study to test the mouthwash, Biotene. Patients (24) will receive either Normal Saline or Biotene mouthwashes. The following data will be collected from each group: 1) severity of mucositis, symptoms experienced and 3) compliance with mouth care. Patients will be randomly assigned and unaware of which mouthwash they are to receive.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36075 0
Address 36075 0
Country 36075 0
Phone 36075 0
Fax 36075 0
Email 36075 0
Contact person for public queries
Name 9239 0
Linda Crowe
Address 9239 0
Nursing Research Centre
Aubigny Place
Level 1
Mater Health Services
Raymond Tce
South Brisbane QLD 4101
Country 9239 0
Australia
Phone 9239 0
+61 7 38408638
Fax 9239 0
+61 7 38402549
Email 9239 0
Linda.Crowe@mater.org.au
Contact person for scientific queries
Name 167 0
Linda Crowe
Address 167 0
Nursing Research Centre
Aubigny Place
Level 1
Mater Health Services
Raymond Tce
South Brisbane QLD 4101
Country 167 0
Australia
Phone 167 0
+61 7 38408638
Fax 167 0
+61 7 38402549
Email 167 0
Linda.Crowe@mater.org.au