None listed
Conditions
Brief summary
Xerostomia or dry mouth is a major problem that many people experience, especially those who have received radiotherapy for the treatment of head and neck cancer and it accompanies other diseases such as Sjögren syndrome. Saliva plays many vital roles in our daily life and people with reduced saliva production can experience a variety of health problems. Pilocarpine is a medication that stimulates the nerves supplying the salivary glands. This stimulates the production of your own saliva. The effect lasts for about three hours, and so it is usually taken three times daily. Pilocarpine is usually taken before a meal to produce more saliva in time for eating. Pilocarpine is only available as eye drops to treat glaucoma in Australia, but tablets are available for treating dry mouth in many countries around the world. This trial investigates pilocarpine orally dissolving tablets (ODTs), which are little tablets that dissolve rapidly in the mouth and can be compounded in pharmacies. This trial will provide information about whether pilocarpine ODTs are effective in treating dry mouth, and this information will help to improve management of dry mouth in Australia. A series of single patient (N-of-1) trials of 5 mg pilocarpine ODTs (intervention) vs placebo ODTs (control) will be run, in people suffering with xerostomia, with a population estimate of the benefit following the combination of multiple SPTs. Participants will complete 18 days of treatment, consisting of 3 cycles. Each cycle contains two periods: 3 days treatment, 3 days placebo. The first day of each period is considered to be the washout and data collected will not be included in analysis. The order of treatment and placebo will be randomly allocated for each cycle. Treatment allocation will be blinded to the participant and the Primary Investigator.
Interventions
Single patient trials (n-of-1 or SPTs) of 5 mg pilocarpine orally dissolving tablets (ODTs) vs placebo ODTs, one tablet orally, 3 times per day for 18 days consisting of 3 cycles. Each cycle contains two periods: 3 days treatment, 3 days placebo. The first day of each period is considered to be the washout and data collected will not be included in analysis. The order of treatment and placebo will be randomly allocated for each cycle. Treatment allocation will be blinded to the participant and
Single patient trials (n-of-1 or SPTs) of 5 mg pilocarpine orally dissolving tablets (ODTs) vs placebo ODTs, one tablet orally, 3 times per day for 18 days consisting of 3 cycles. Each cycle contains two periods: 3 days treatment, 3 days placebo. The first day of each period is considered to be the washout and data collected will not be included in analysis. The order of treatment and placebo will be randomly allocated for each cycle. Treatment allocation will be blinded to the participant and the Primary Investigator. Participants will take one dose of trial medication 60 minutes prior to breakfast, lunch and dinner, each day for the 18 day trial. They will collect saliva samples in pre-labelled tubes 60 minutes after taking the breakfast and dinner doses, just before eating. Participants will complete a daily diary recording symptom scores using validated measures for dry mouth and related symptoms, the presence of any side effects and their estimate of which drug they believe they are taking at the time. The principal investigator will call every participant every 3 days to check their compliance with the medication and completing the daily diary and if there are any adverse effects or serious adverse effects.
Sponsors
University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
•Males and females aged 18 years or older. •To ensure that xerostomia is significant enough to warrant treatment with pilocarpine, participants must self-report xerostomia of any etiology as a score of 3 or more on a numerical rating scale (NRS) from 0 – 10 (where 0 = no dry mouth and 10 = worst possible dry mouth) . •As pilocarpine action requires some residual salivary function, participants must self-report evidence of saliva production in the mouth upon chewing a piece of gum . •Participants are able and willing to give appropriate informed consent.
Exclusion criteria
•Ocular problems contraindicating the use of parasympathetic agents (e.g. irido-cyclitis, increased intra-ocular pressure); •Other comorbidity where there is a risk of worsening co-existing medical problems during the trial period and/or active treatment is contemplated. For example, severe or uncontrolled asthma or pulmonary disease, uncontrolled hypotension or hypertension, hyperthyroidism, uncontrolled seizures or cardiac arrythmias, (especially bradycardias) and Parkinson's disease. If these diseases are well controlled, they do not constitute exclusion criteria. •An active oral infection i.e. candidiasis, herpetic infections, mucositis, mouth ulcers; •Suspected or confirmed pregnancy; •Intervention (e.g. radiotherapy, chemotherapy, surgery that might alter dry mouth symptoms during the 2 weeks prior to the study period or plans to undergo such therapy during the study period; •Plans to change any medication with the potential to cause dry mouth within the trial period; •Plans to use any other prescribed medication which is known to increase saliva production and relieve dry mouth during the trial period. Patients already on pilocarpine are eligible, but must stop taking it 1 week before trial commencement; •A poor understanding of written or spoken English that would preclude completion of all trial requirements
Outcome results
None listed