Testing pilocarpine drops for dry mouth in advanced cancer using n-of-1 trials: A feasibility study. (December 2015)

• Record Type: Journal Article
• Authors: Nikles, Jane; Mitchell, Geoffrey K; Hardy, Janet; Agar, Meera; Senior, Hugh; Carmont, Sue-Ann; Schluter, Philip J; Good, Phillip; Vora, Rohan; Currow, David
• Is Part Of: Palliative medicine. Volume 29:Number 10(2016)
• Page Start: 967
• Page End: 974
• Publication Date: 2015-12
• Subjects: Pilocarpine -- palliative care -- xerostomia -- neoplasms -- feasibility studies -- clinical trial -- crossover trials; Pain -- Treatment -- Periodicals; Cancer -- Palliative treatment -- Periodicals; Palliative Care -- Periodicals; Palliatieve behandeling; 616.029
• DOI: 10.1177/0269216315585473
• Languages: English
• ISSNs: 0269-2163

Abstract

Background: Dry mouth is a common and troublesome symptom in palliative care. Pilocarpine is a cholinergic agent that promotes salivation. Aim: This study aimed to test the feasibility of using n -of-1 trials to test pilocarpine drops compared to placebo, for patients of palliative care units with advanced cancer, who experienced dry mouth. Design: This was an N-of-1 study, in which each participant was offered three cycles of pilocarpine drops 4% (6 mg tds) (3 days) and placebo drops (3 days) in random order. Setting/participants: Participants were patients of specialist palliative care services with advanced cancer assessed as having a dry mouth, defined as having a score of ⩾3 on an 11-point self-rated xerostomia numerical rating scale, from any cause. 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 decisions for individual patients to be made. Results: Nine patients completed at least 1 cycle; 33 cycles of data were completed in total, comprising 438 doses of pilocarpine. Four patients completed the trial: two responded and two did not. Most withdrawals related to deteriorating condition, unacceptable toxicity, non-compliance with study procedures or withdrawal of consent. Many issues contributed to slow recruitment and high withdrawal rate. Conclusion: The formulation of pilocarpine drops proved unacceptable to most participants. More work is required to determine an appropriate formulation, dose and method of delivery and then a retest of pilocarpine drops for this symptom.