None listed
Conditions
Interventions
Active pilocarpine 4% (40 mg/ml) drops; Pilcoarpine (po) 2-3 drops 3 times daily (4-6 mg three times daily) with meals in raspberry water delivered as a mouth dropper.
Rasberry water is combined with the active treatment in order to simulate the taste of the placebo, rasberry water. This is to ensure the patient remains blind to the treatment.
The active treatment will be administered in a cycle pair. A cycle pair is a course of treatment over 6 days. For 3 consecutive days, the patient will
Active pilocarpine 4% (40 mg/ml) drops; Pilcoarpine (po) 2-3 drops 3 times daily (4-6 mg three times daily) with meals in raspberry water delivered as a mouth dropper. Rasberry water is combined with the active treatment in order to simulate the taste of the placebo, rasberry water. This is to ensure the patient remains blind to the treatment. The active treatment will be administered in a cycle pair. A cycle pair is a course of treatment over 6 days. For 3 consecutive days, the patient will take the active treatment followed by 3 days on placebo. The duration of the trial will consist of 3 cycle pairs taking place over 18 days. A follow-up on day 19 by the patients physician will then take place. A washout period will be instigated on the first day of each cycle. On that day, no measurements will be taken.
Sponsors
University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged >=18 years with advanced malignant disease; 2. a clinical diagnosis of chronic dry mouth that has been present for at least 2 weeks with no likelihood of resolution during the trial period 3. a numerical rating scale (NRS) score of >=3 on a 10-point xerostomia scale; 4. liver function (Asparate Transaminase (AST), Alanine Transaminase (ALT)) =< 1.5x upper limit of normal, and total bilirubin within normal range within the week prior to trial registration; 5. no known allergy or sensitivity to pilocarpine; 6. ability to give fully informed written consent and complete all trial requirements.
Exclusion criteria
1. no plan to change any medication with the potential to cause dry mouth within the trial period. Patients already on pilocarpine are eligible but must stop these drugs 1 week before trial commencement. 2. no 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 3. ocular problems contraindicating the use of parasympathetic agents (eg irido-cyclitis, increased intra-ocular pressure); 4. other comorbidity where there is a risk of worsening co-existing medical problems during the trial period and/or active treatment is contemplated eg severe or uncontrolled asthma or pulmonary disease, uncontrolled hypo-or hypertension, hyperthyroidism, uncontrolled seizures or cardiac arrythmias, (especially bradycardias) and Parkinson's disease; 5. a poor understanding of written or spoken English that would preclude completion of all trial requirements 6. an active oral infection i.e. candidiasis, herpetic infections, mucositis, mouth ulcers
Outcome results
None listed