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Trial registered on ANZCTR
Registration number
ACTRN12619000697189
Ethics application status
Approved
Date submitted
1/05/2019
Date registered
9/05/2019
Date last updated
2/02/2022
Date data sharing statement initially provided
9/05/2019
Date results information initially provided
2/02/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
Oral Pilocarpine tablets for advanced cancer patients with dry mouth.
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Scientific title
Oral Pilocarpine tablets for Xerostomia in patients with advanced cancer – an N-of-1 feasibility pilot study
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Secondary ID [1]
297961
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None
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Universal Trial Number (UTN)
None
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Trial acronym
OPX
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Linked study record
N/A
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Health condition
Health condition(s) or problem(s) studied:
xerostomia
312358
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Condition category
Condition code
Cancer
310915
310915
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0
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Any cancer
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Oral and Gastrointestinal
311176
311176
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
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Intervention code [1]
314180
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Treatment: Drugs
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Comparator / control treatment
Control group: Placebo (matching Oral Dissolvable Tablets). Identical dosing schedule to treatment.
Placebo made from flavour powder, bitterness reducing agent, stevia powder, Medi-RDT Base.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Number of participants recruited over the study period who complete all trial requirements.
Master Log of participants whom reach Day 18 of the trial, and complete the daily Participant Diary which includes:
Numerical Rating Scale and Xerostomia Inventory
Oral Health Impact Profile
Patient Global Impact of Change
common side effects
medication compliance
changes in conmeds
preferred medicine after each cycle
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Assessment method [1]
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Timepoint [1]
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Day 18
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Secondary outcome [1]
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Mean NRS score for average dry mouth
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Assessment method [1]
369347
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Timepoint [1]
369347
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over the previous 24 hours on days 2 and 3 of each cycle pair
A cycle pair is 3 days of active drug and 3 days of placebo (Random order).
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Secondary outcome [2]
369348
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Number of participants in whom a decision can be made regarding the benefit or otherwise of ODT versus placebo using N-of-1 methodology.
Participant diary questionnaires:
Numerical Rating Scale and Xerostomia Inventory
Oral Health Impact Profile
Patient Global Impact of Change
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Assessment method [2]
369348
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Timepoint [2]
369348
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Day 18
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Secondary outcome [3]
369351
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Adverse Events - National Cancer Institute, Common Terminology Criteria for Adverse Events. V4.0 (2010)
- increased sweating
- headache
- nausea/vomiting
- dizziness
- muscle tremors
- breathing difficulties
- abdominal discomfort
- dysgeusia
- excess saliva
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Assessment method [3]
369351
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Timepoint [3]
369351
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every third day of each 6-day cycle for 18 days
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Secondary outcome [4]
369352
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Patients Global Impression of change (PGIC)
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Assessment method [4]
369352
0
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Timepoint [4]
369352
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every third day of each 6-day cycle
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Secondary outcome [5]
369353
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NRS for dysphagia
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Assessment method [5]
369353
0
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Timepoint [5]
369353
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daily for 18 days
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Secondary outcome [6]
369354
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Xerostomia Inventory scores (XI)
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Assessment method [6]
369354
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Timepoint [6]
369354
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every third day of each 6-day cycle
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Secondary outcome [7]
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Oral Health Impact Profile (OHIP)
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Assessment method [7]
369355
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Timepoint [7]
369355
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every third day of each 6-day cycle
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Secondary outcome [8]
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NRS for dysgeusia
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Assessment method [8]
369960
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Timepoint [8]
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daily for 18 days
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Schedule kept by central pharmacy to allocate and dispense.
Drug concealed by numbering system - bottles 1-6.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N-of-1 design sequence generated by computer software.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
single patient multiple crossover studies
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Phase
Phase 2 / Phase 3
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Based on prior clinical trial experience, 15 participants will give an adequate sample size to define the feasibility, and determine if this method could be used as the basis for future multi-centre studies with the ability to recruit adequate numbers of participants to answer clinically important research questions. Descriptive statistics will be provided for demographic and secondary outcome measures including safety data. Individual and population treatment differences will be calculated using hierarchical Bayesian methods and employ non-informative priors in the first instance – following the method of Zucker et al (1997) for normally distributed data and Schluter and Ware (2005) for binary data.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
30/06/2020
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Actual
10/07/2020
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Date of last participant enrolment
Anticipated
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Actual
9/11/2021
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Date of last data collection
Anticipated
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Actual
4/12/2021
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Sample size
Target
15
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Accrual to date
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Final
18
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
13658
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Mater Adult Hospital - South Brisbane
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Recruitment hospital [2]
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Mater Private Hospital - South Brisbane
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Recruitment postcode(s) [1]
26341
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4101 - South Brisbane
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Mater Misericordiae Ltd
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Address [1]
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Raymond Tce
South Brisbane, Qld, 4101
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Country [1]
302480
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Australia
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Primary sponsor type
Hospital
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Name
Mater Misericordiae Ltd
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Address
Raymond Tce
South Brisbane, Qld, 4101
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Country
Australia
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Secondary sponsor category [1]
302505
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None
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Name [1]
302505
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Address [1]
302505
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Country [1]
302505
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
303142
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Mater Misericordiae Ltd Human Research Ethics Committee
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Ethics committee address [1]
303142
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Raymond Tce
South Brisbane, Qld 4101
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Ethics committee country [1]
303142
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Australia
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Date submitted for ethics approval [1]
303142
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Approval date [1]
303142
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15/04/2019
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Ethics approval number [1]
303142
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HREC/MML/49208
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Summary
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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Evan Richard
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Address
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Mater Misericordiae Ltd, Raymond Tce, South Brisbane, Qld, 4101.
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Country
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Australia
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Phone
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+61 7 3163 8111
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Mrs Karyn Foster
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Address
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Mater Misericordiae Ltd, Raymond Tce, South Brisbane, Qld, 4101.
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Country
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Australia
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Phone
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+61 7 3163 3884
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof Janet Hardy
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Address
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Mater Misericordiae Ltd, Raymond Tce, South Brisbane, Qld, 4101.
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Country
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Australia
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Phone
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+61 7 3163 8111
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Local Pilot study only
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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.
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