title: Do pilocarpine drops help dry mouth in palliative care patients: a protocol for an aggregated series of n-of-1 trials.
abstract: BACKGROUND
  It is estimated that 39,000 Australians die from malignant disease yearly. Of these, 60% to 88% of advanced cancer patients suffer xerostomia, the subjective feeling of mouth dryness. Xerostomia has significant physical, social and psychological consequences which compromise function and quality of life. Pilocarpine is one treatment for xerostomia. Most studies have shown some variation in individual response to pilocarpine, in terms of dose used, and timing and extent of response.We will determine a population estimate of the efficacy of pilocarpine drops (6 mg) three times daily compared to placebo in relieving dry mouth in palliative care (PC) patients. A secondary aim is to assess individual patients' response to pilocarpine and provide reports detailing individual response to patients and their treating clinician.
  
  
  METHODS
  Aggregated n-of-1 trials (3 cycle, double blind, placebo-controlled crossover trials using standardized measures of effect). Individual trials will identify which patients respond to the medication. To produce a population estimate of a treatment effect, the results of all cycles will be aggregated.
  
  
  CONCLUSIONS
  Managing dry mouth with treatment supported by the best possible evidence will improve functional status of patients, and improve quality of life for patients and carers. Using n-of-1 trials will accelerate the rate of accumulation of high-grade evidence to support clinical therapies used in PC.
  
  
  BACKGROUND
  Australia and New Zealand Clinical Trial Registry Number: 12610000840088.
authors.affiliation: School of Medicine, The University of Queensland, Brisbane, Australia. uqjnikle@uq.edu.au.
authors.forename: Jane
authors.initials: J
authors.lastname: Nikles
authors.forename: Geoffrey K
authors.initials: GK
authors.lastname: Mitchell
authors.forename: Janet
authors.initials: J
authors.lastname: Hardy
authors.forename: Meera
authors.initials: M
authors.lastname: Agar
authors.forename: Hugh
authors.initials: H
authors.lastname: Senior
authors.forename: Sue-Ann
authors.initials: SA
authors.lastname: Carmont
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Schluter
authors.forename: Phillip
authors.initials: P
authors.lastname: Good
authors.forename: Rohan
authors.initials: R
authors.lastname: Vora
authors.forename: David
authors.initials: D
authors.lastname: Currow