Oral Pilocarpine tablets for Xerostomia in patients with advanced cancer – an N-of-1 feasibility pilot study

Mater Misericordiae Ltd0 个研究点目标入组 18 人开始时间: 2019年5月9日最近更新: 2022年2月7日

适应症

试验速览

暂无简介。

•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.

•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

发起方