None listed
Conditions
Brief summary
This study will evaluate the feasibility and efficacy of pilocarpine on xerostomia for patients with cancer Who is it for? You may be eligible to join this study if you are aged 18 and above, have been diagnosed with cancer and xerostomia Study details Participants in this study will receive both the interventional drug and placebo drug but in a random sequence. At the beginning of the study, Participants will receive 6 bottles of drug. 3 bottles contain placebo and 3 contain the drug pilocarpine. The 6 bottles will be taken randomly as instructed by the pharmacy over 18 days. Participants will not know which bottle has what drug. The drug will be taken three times a day for the 18 day trial. All participants will complete a diary which will provide information around dry mouth symptoms, and document any adverse events/side effects experienced. We hope that this drug and formulation will be able to help cancer patients in the future who suffer from the debilitating symptom of chronic dry mouth.
Interventions
Treatment group: Pilocarpine 5mg Oral Dissolvable Tablets; one tablet orally, three times per day (5 mg per dose) 60 minutes before each main meal (breakfast, lunch, dinner) for 3 days. Placebo Oral Dissolvable Tablets; one tablet orally, three times per day -60 minutes before each main meal (breakfast, lunch, dinner) for 3 days. This is 1 cycle, with 3 cycles in total - in random order.
The washout period is 24hrs. Day 2 and 3 data are included in the analysis.
Tablets are returned at the end
Treatment group: Pilocarpine 5mg Oral Dissolvable Tablets; one tablet orally, three times per day (5 mg per dose) 60 minutes before each main meal (breakfast, lunch, dinner) for 3 days. Placebo Oral Dissolvable Tablets; one tablet orally, three times per day -60 minutes before each main meal (breakfast, lunch, dinner) for 3 days. This is 1 cycle, with 3 cycles in total - in random order. The washout period is 24hrs. Day 2 and 3 data are included in the analysis. Tablets are returned at the end of the trial to study staff. The participant diary documents daily doses taken/not taken. Third daily phone calls monitor compliance with medication.
Sponsors
Mater Misericordiae Ltd
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
1. Patients aged >=18 years with 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 (AST, ALT) <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