title: Testing pilocarpine drops for dry mouth in advanced cancer using n-of-1 trials: A feasibility study.
abstract: BACKGROUND
  Dry mouth is a common and troublesome symptom in palliative care. Pilocarpine is a cholinergic agent that promotes salivation.
  
  
  OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: The School of Medicine, The University of Queensland, Ipswich, QLD, 4035, Australia uqjnikle@uq.edu.au.
authors.forename: Jane
authors.initials: J
authors.lastname: Nikles
authors.affiliation: The School of Medicine, The University of Queensland, Ipswich, QLD, 4035, Australia.
authors.forename: Geoffrey K
authors.initials: GK
authors.lastname: Mitchell
authors.affiliation: Cancer Biology and Management, Mater Research Institute, The University of Queensland, Brisbane, QLD, Australia Department of Palliative and Supportive Care, Mater Health Services, The University of Queensland, Brisbane, QLD, Australia.
authors.forename: Janet
authors.initials: J
authors.lastname: Hardy
authors.affiliation: Department of Palliative Care, Braeside Hospital, Fairfield, NSW, Australia.
authors.forename: Meera
authors.initials: M
authors.lastname: Agar
authors.affiliation: The School of Medicine, The University of Queensland, Ipswich, QLD, 4035, Australia.
authors.forename: Hugh
authors.initials: H
authors.lastname: Senior
authors.affiliation: The School of Medicine, The University of Queensland, Ipswich, QLD, 4035, Australia.
authors.forename: Sue-Ann
authors.initials: SA
authors.lastname: Carmont
authors.affiliation: School of Health Sciences, University of Canterbury, Christchurch, New Zealand School of Nursing and Midwifery, The University of Queensland, Brisbane, QLD, Australia.
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Schluter
authors.affiliation: Cancer Biology and Management, Mater Research Institute, The University of Queensland, Brisbane, QLD, Australia Department of Palliative and Supportive Care, Mater Health Services, The University of Queensland, Brisbane, QLD, Australia St Vincent's Private Hospital, Brisbane, QLD, Australia.
authors.forename: Phillip
authors.initials: P
authors.lastname: Good
authors.affiliation: Department of Palliative Care, Gold Coast Health Service District, Gold Coast, QLD, Australia.
authors.forename: Rohan
authors.initials: R
authors.lastname: Vora
authors.affiliation: Discipline of Palliative and Supportive Services, Flinders University, Bedford Park, SA, Australia.
authors.forename: David
authors.initials: D
authors.lastname: Currow
mesh_terms: D000278:Administration, Buccal; D002471:Cell Transformation, Neoplastic; D018678:Cholinergic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D018592:Cross-Over Studies; D005240:Feasibility Studies; D017051:Hospice Care / Q000379:methods / Q000592:standards; D006801:Humans; D009369:Neoplasms / Q000150:complications* / Q000188:drug therapy; D010166:Palliative Care / Q000379:methods*; D010862:Pilocarpine / Q000008:administration & dosage / Q000627:therapeutic use*; D012472:Salivation / Q000187:drug effects*; D014987:Xerostomia / Q000188:drug therapy* / Q000209:etiology
chemical_list: D018678:Cholinergic Agents; D010862:Pilocarpine
keywords: Pilocarpine; clinical trial; crossover trials; feasibility studies; neoplasms; palliative care; xerostomia