Testing the effectiveness of pilocarpine drops for dry mouth in advanced cancer using aggregated n-of-1 trials: a pilot study

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dc.contributor.authorNikles, J.
dc.contributor.authorMitchell, G.K.
dc.contributor.authorHardy, J.
dc.contributor.authorAgar, M.
dc.contributor.authorSenior, H.
dc.contributor.authorCarmont, S.A.
dc.contributor.authorSchluter, P.J.
dc.contributor.authorGood, P.
dc.contributor.authorVora, R.
dc.contributor.authorCurrow, D.
dc.date.accessioned2016-02-09T02:12:49Z
dc.date.available2016-02-09T02:12:49Z
dc.date.issued2015en
dc.description.abstractPurpose : Dry mouth is a common and troublesome symptom in palliative care. Pilocarpine is a cholinergic agent that promotes salivation. We aimed to test the effectiveness of pilocarpine drops compared to placebo, for participants with advanced cancer, who experienced dry mouth. Method : Aggregated n-of-1 trials for patients of specialist palliative care services with advanced cancer assessed as having a dry mouth. Each participant was offered three cycles of pilocarpine drops 4%, 6 mg tds (3 days) and placebo drops (3 days) in random order. Patients self-completed a diary using validated symptom and quality of life scores. The randomisation order was unmasked at the end of each person’s trial by a clinician independent of the trial to allow a treatment decision for individual patients to be made. Results : Twenty people were recruited to this pilot study, of whom five completed the planned three cycles; 36 cycles of data were completed in total. 438 doses of pilocarpine were administered. Most withdrawals related to deteriorating condition, unacceptable toxicity, non-compliance with study procedures or withdrawal of consent. Overall, no clinical difference in relief of dry mouth was noted on two measures of dry mouth, and an oral health related quality of life scale. Conclusion : The formulation of pilocarpine drops proved unacceptable to most participants. More work is required to determine an appropriate dose and method of delivery, then a retest of pilocarpine drops for this symptom.en
dc.identifier.citationNikles, J., Mitchell, G.K., Hardy, J., Agar, M., Senior, H., Carmont, S.A., Schluter, P.J., Good, P., Vora, R., Currow, D. (2015) Testing the effectiveness of pilocarpine drops for dry mouth in advanced cancer using aggregated n-of-1 trials: a pilot study. Palliative Medicine, 29(10), pp. 967-974.en
dc.identifier.doihttps://doi.org/10.1177/0269216315585473
dc.identifier.urihttp://hdl.handle.net/10092/11793
dc.language.isoen
dc.publisherUniversity of Canterbury. School of Health Sciencesen
dc.rights.urihttps://hdl.handle.net/10092/17651
dc.subjectpalliative careen
dc.subjectxerostomiaen
dc.subjectpilocarpineen
dc.subjectn-of-1 trialen
dc.subjectadvanced canceren
dc.subject.anzsrcFields of Research::32 - Biomedical and clinical sciences::3211 - Oncology and carcinogenesis::321104 - Cancer therapy (excl. chemotherapy and radiation therapy)en
dc.subject.anzsrcFields of Research::32 - Biomedical and clinical sciences::3214 - Pharmacology and pharmaceutical sciences::321402 - Clinical pharmacology and therapeuticsen
dc.titleTesting the effectiveness of pilocarpine drops for dry mouth in advanced cancer using aggregated n-of-1 trials: a pilot studyen
dc.typeJournal Article
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