Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000199819
Ethics application status
Not yet submitted
Date submitted
7/02/2012
Date registered
16/02/2012
Date last updated
16/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of attenuated Botulinium Toxin to prevent long term loss of salivary secretion in patients undergoing radiation of the head & neck for malignancies
Scientific title
The use of attenuated Botulinium Toxin to prevent long term loss of salivary secretion in patients undergoing radiation of the head & neck for malignancies
Secondary ID [1] 279897 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Xerostomia (dry mouth) post bilateral irradation of salivary glands in the field of radiotherapy. 285803 0
Condition category
Condition code
Oral and Gastrointestinal 285979 285979 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 286047 286047 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose of attenuated botulinum toxin (100units), delivered directly via subcutanous injection into the parotid gland through the skin. 3-4 days prior to radiation treatment
Intervention code [1] 284220 0
Prevention
Intervention code [2] 284277 0
Treatment: Other
Comparator / control treatment
All patients who receive bilateral neck irradiation
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286474 0
Any salivary gland function (patient questionairre)
Timepoint [1] 286474 0
3 months post radiation
Secondary outcome [1] 295956 0
Clinical assesment including a sheet assessing patient's subjective perception of symptoms, and also a clinician's objective assessment.
Timepoint [1] 295956 0
3 months post radiation

Eligibility
Key inclusion criteria
>20 years old. Existing head and neck cancer. Radiation as the primary treatment modality. Bilateral submandibular irradiation
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No preexisting salivary gland disease

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patient seen at the Head and Neck OPD are advised that they are eligible. They receive an appointment with the Radiation Oncologist to assess suitability.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be identified and their results recorded at each appointment
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT

Funding & Sponsors
Funding source category [1] 284666 0
University
Name [1] 284666 0
Royal Darwin Hospital
Country [1] 284666 0
Australia
Primary sponsor type
Hospital
Name
Royal Darwin Hospital
Address
PO BOX 41326
Casuarina NT 0811
Country
Australia
Secondary sponsor category [1] 283571 0
None
Name [1] 283571 0
Address [1] 283571 0
Country [1] 283571 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286671 0
Menzies School of Health Research
Ethics committee address [1] 286671 0
PO Box 41096
Casuarina NT0811
Ethics committee country [1] 286671 0
Australia
Date submitted for ethics approval [1] 286671 0
21/03/2012
Approval date [1] 286671 0
Ethics approval number [1] 286671 0

Summary
Brief summary
This study is looking at the use of attenuated Botulinium Toxin to prevent long term loss of salivary secretion in patients undergoing radiation of the head & neck for malignancies. Botulinium Toxin is used to protect the parotid gland, responsible for 60% of resting saliva, from irradiation, and will be administered via a subcutaneous injection of the attenuated botulinum toxin delivered directly into the parotid gland through the skin. This will cause the gland to slow down, and therefore avoid becoming the target of irradiation. Xerostomia (or dry mouth) is a dehabilitating condition which is inevitable in bilateral neck irradiation for the treatment of head and neck cancers Trial Details In this study you will receive a single dose of attenuated botulinum toxin (100units), delivered via subcutaneous injection directly into the parotid gland through the skin 3-4 days prior to your scheduled radiation treatment. Who is it for? This study is available for participants 20 years and over who are undergoing radiation as the primary treatment modality, and have bilateral submandibular irradiation with existing head and neck cancer
Trial website
Nil
Trial related presentations / publications
Nil yet
Public notes

Contacts
Principal investigator
Name 33747 0
Address 33747 0
Country 33747 0
Phone 33747 0
Fax 33747 0
Email 33747 0
Contact person for public queries
Name 16994 0
Dr Eileen TAN-GORE
Address 16994 0
Royal Darwin Hospital
PO Box 41326
Casuarina NT 0811
Country 16994 0
Australia
Phone 16994 0
61 08 8922 8888
Fax 16994 0
Email 16994 0
[email protected]
Contact person for scientific queries
Name 7922 0
Dr Eileen TAN-GORE
Address 7922 0
Royal Darwin Hospital
PO Box 41326
Casuarina NT 0811
Country 7922 0
Australia
Phone 7922 0
61 08 8922 8888
Fax 7922 0
Email 7922 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.