None listed
Conditions
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
Interventions
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 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.
Sponsors
Jules Kieser
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed