ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

Nil

Universal Trial Number (UTN)

U1111-1142-6873

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

xerostomia

Condition category

Condition code

Oral and Gastrointestinal

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]

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]

Test of Mastication and Swallowing Solids (TOMASS)

Timepoint [1]

The trial tests responses both immediately and after 1 week of use

Primary outcome [2]

Subjective feeling of xerostomia as assessed using the Xerostomia Inventory.

Timepoint [2]

The trial tests responses both immediately and after 1 week of use

Primary outcome [3]

Patient acceptability as measured using a visual analogue scale.

Timepoint [3]

The trials tests responses both immediately and after 1 week of use

Secondary outcome [1]

nil

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Canterbury

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Otago
Faculty of Dentistry

Address [1]

PO Box 647
Dunedin 9054

Country [1]

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]

None

Name [1]

nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Central Health and Disability Ethics Committee

Ethics committee address [1]

1 The Terrace
PO Box 5013
Wellington 6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

25/06/2013

Approval date [1]

Ethics approval number [1]

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

Dr Olivia Apperley

Address

University of Otago
25 Highcrest Heights
Westmorland
Christchurch 8025

Country

New Zealand

Phone

+64211219748

Fax

oliviaapperley@yahoo.co.nz

Contact person for public queries

Name

Olivia Apperley

Address

University of Otago
25 Highcrest Heights
Westmorland
Christchurch 8025

Country

New Zealand

Phone

+64211219748

Fax

oliviaapperley@yahoo.co.nz

Contact person for scientific queries

Name

Olivia Apperley

Address

University of Otago
25 Highcrest Heights
Westmorland
Christchurch 8025

Country

New Zealand

Phone

+64211219748

Fax

oliviaapperley@yahoo.co.nz

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically