Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000827730
Ethics application status
Not yet submitted
Date submitted
22/07/2013
Date registered
26/07/2013
Date last updated
26/07/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Management of dry mouth following radiation therapy: investigation of a new saliva substitute product.
Scientific title
Management of xerostomia following radiotherapy: a randomised, double blind, cross-over study of a novel emulsion for use as a saliva substitute
Secondary ID [1] 282848 0
Nil
Universal Trial Number (UTN)
U1111-1142-6873
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
xerostomia 289656 0
Condition category
Condition code
Oral and Gastrointestinal 289976 289976 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a novel emulsion developed at the University of Otago School of Pharmacy and Sir John Walsh Research Institute which consists of rice bran oil, soy lecithin, propylene glycol and water.
The saliva substitute will be delivered in a metered dose spray bottle. The participant will be asked to use the product at least 4 times per day but more if they wish for one week. They will be asked how often they use the product and how many sprays were required each time. The contents of the return bottle at the end of one week will be measured.
Participants will be asked to use either an active treatment or placebo in a randomised order for one week. There will be a one week wash out period followed by one week use of the alternative product.
Intervention code [1] 287540 0
Treatment: Other
Comparator / control treatment
The test product will be compared against 2 products
1) An active control of carboxymethylcellulose saliva substitute, which is currently the only publicly funded saliva substitute available in New Zealand
2) A placebo of water with a flavour added.

Each product will be delivered in a metered dose spray bottle. The participant will be asked to use the product at least 4 times per day but more if they wish for one week. They will be asked how often they use the product and how many sprays were required each time. The contents of the return bottle at the end of one week will be measured.
Control group
Placebo

Outcomes
Primary outcome [1] 290069 0
Test of Mastication and Swallowing Solids (TOMASS)
Timepoint [1] 290069 0
The trial tests responses both immediately and after 1 week of use
Primary outcome [2] 290070 0
Subjective feeling of xerostomia as assessed using the Xerostomia Inventory.
Timepoint [2] 290070 0
The trial tests responses both immediately and after 1 week of use
Primary outcome [3] 290071 0
Patient acceptability as measured using a visual analogue scale.
Timepoint [3] 290071 0
The trials tests responses both immediately and after 1 week of use
Secondary outcome [1] 303887 0
nil
Timepoint [1] 303887 0
nil

Eligibility
Key inclusion criteria
It is a requirement that participants have received radiation therapy to the head and neck region within the last 10 years at Christchurch Hospital.
Participants will be asked a global question regarding xerostomia. "How often does your mouth feel dry?"
Responses are: ‘Never’, ‘Occasionally’, ‘Frequently’, ‘Always’.
Participants who respnd ‘Frequently’ and ‘Always’ will be considered to have xerostomia and will be included in the trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who have had surgery as well as radiation therapy for head and neck cancer will not be included. Those who cannot safely swallow solid food will not be included.

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)
Participants will be given the opportunity to participate when they attend routine appointments with their usual oral health care provider (not the primary investigator). They will be provided with information on what the trial involved and have the opportunity to ask questions. They will then sign a consent form.
The participants will be allocated to one of 2 crossover groups by way of random numbers generated by computer. Odd number will be allocated to group one - trial of the new emulsion against a placebo of water
Even number will be allocated to group 2 - trial of carboxymethylcellulose against a placebo of water.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each participant will then have the order that they receive either the intervention or the placebo randomised by way of random number generation by computer.
A research assistant will put together a randomisation table which will be given to the pharmacist making up the test products. Each bottle will look identical but will be given a unique number on the label according to the randomisation table which ensures the primary investigator does not see which product each participant is using.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A power calculation was carried out using data from a previous study involving participants with Parkinsons disease using TOMASS as an outcome measure. This calculation indicated a sample size of 34 was required, therefore for this trial a sample size of 40 was chosen to allow for drop-out.
For the outcome measures of the xerostomia inventory and the visual analogue scale a multiple linear regression model will be used to assess the difference in each group, adjusting for a difference in sequence of the products.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2013
Actual
Date of last participant enrolment
Anticipated
1/09/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 5238 0
New Zealand
State/province [1] 5238 0
Canterbury

Funding & Sponsors
Funding source category [1] 287668 0
University
Name [1] 287668 0
University of Otago
Faculty of Dentistry
Country [1] 287668 0
New Zealand
Primary sponsor type
Individual
Name
Jules Kieser
Address
Sir John Walsh Research Institute
University of Otago
Faculty of Dentistry
PO Box 647
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 286404 0
None
Name [1] 286404 0
nil
Address [1] 286404 0
Country [1] 286404 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289632 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 289632 0
1 The Terrace
PO Box 5013
Wellington 6011
Ethics committee country [1] 289632 0
New Zealand
Date submitted for ethics approval [1] 289632 0
25/06/2013
Approval date [1] 289632 0
Ethics approval number [1] 289632 0

Summary
Brief summary
Healthy saliva cleanses and lubricates the mouth, it protects the teeth by reducing bacteria and neutralising acid, and plays a crucial role in tasting, chewing and swallowing of food. A well documented side-effect of radiotherapy for treatment of cancer of the head and neck is a dry mouth due to damage of the surrounding salivary glands (Wijers et al 2002). Such a decrease in saliva flow following radiotherapy results in significant compromise of quality of life and has been shown to lead to an increase in tooth decay and infections in the mouth and cause difficulty with eating and swallowing.
Researchers at the Sir John Walsh Research Institute and the Department of Pharmacy at the University of Otago have recently developed a novel oily formulation for the treatment of dry mouth, to act as a saliva substitute. The aim of this randomised, double blinded, within-subject study is to trial the new formulation as a saliva substitute on measures of mastication, subjective feeling of oral dryness and product acceptibility, and compare outcomes to a currently available saliva substitute and a control of water. Forty participants who have been treated with radiotherapy to the head and neck region will be selected to participate in the trial. Participants will be randomised to receive mouth spray presentations of either an existing saliva substitute or the new formulation; both will use water as a control condition. The researchers and the participants will be blind as to the contents of each spray bottle which will be prepared and labelled in the pharmacy and distributed by a dental assistant.
The differences in each product will be measured using three tests. The first is a simple behavioural test of chewing and swallowing, the second is a questionnaire designed to test the subjective feeling of dry mouth and the third is a questionnairre designed to test the patient acceptibility of each product. Outcome data will be gathered in a single session after the first administration of both the products and placebos to evaluate immediate effects, and after 7 days of use to evaluate longer-term effects. Order of the 7 day use of test product or placebo will be randomised.
The results of this trial will be used in further development of the new saliva substitute, which potentially could influence quality of life and swallowing safety in patients after radiotherapy treatment
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41506 0
Dr Olivia Apperley
Address 41506 0
University of Otago
25 Highcrest Heights
Westmorland
Christchurch 8025
Country 41506 0
New Zealand
Phone 41506 0
+64211219748
Fax 41506 0
Email 41506 0
[email protected]
Contact person for public queries
Name 41507 0
Dr Olivia Apperley
Address 41507 0
University of Otago
25 Highcrest Heights
Westmorland
Christchurch 8025
Country 41507 0
New Zealand
Phone 41507 0
+64211219748
Fax 41507 0
Email 41507 0
[email protected]
Contact person for scientific queries
Name 41508 0
Dr Olivia Apperley
Address 41508 0
University of Otago
25 Highcrest Heights
Westmorland
Christchurch 8025
Country 41508 0
New Zealand
Phone 41508 0
+64211219748
Fax 41508 0
Email 41508 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

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