Oral Pilocarpine tablets for advanced cancer patients with dry mouth.

Phase 2

Completed

• Conditions: xerostomia; Cancer - Any cancer; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12619000697189
• Lead Sponsor: Mater Misericordiae Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-09
• Study Completion: 2021-12-04
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of participants recruited over the study period who complete all trial requirements.<br>Master Log of participants whom reach Day 18 of the trial, and complete the daily Participant Diary which includes:<br>Numerical Rating Scale and Xerostomia Inventory<br>Oral Health Impact Profile<br>Patient Global Impact of Change<br>common side effects<br>medication compliance<br>changes in conmeds<br>preferred medicine after each cycle<br><br>[Day 18]