Pilocarpine in Treating Patients With Dry Mouth Caused by Opioids
RATIONALE: Pilocarpine may help to relieve dry mouth in patients receiving opioids for cancer therapy. It is not yet known whether pilocarpine is more effective than no further treatment for this condition.
PURPOSE: Randomized phase III trial to determine the effectiveness of pilocarpine in treating patients who have dry mouth caused by opioids.
|Oral Complications Quality of Life||Drug: pilocarpine hydrochloride Drug: Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
|Official Title:||A Double Blind Phase III Study of Oral Pilocarpine for Opioid-Induced Dry Mouth|
- Efficacy [ Time Frame: 10 years ]To evaluate, using a 100 mm VAS, the effectiveness of oral pilocarpine 5 mg qid in relieving dry mouth due to the ongoing use of an opioid for cancer related pain at 2 weeks (day 15). This will include comparing the proportion of at least one response during the 2 week period, time to first response and duration of first response.
|Study Start Date:||August 1998|
|Study Completion Date:||November 1999|
|Primary Completion Date:||October 1999 (Final data collection date for primary outcome measure)|
|Active Comparator: Pilocarpine||
Drug: pilocarpine hydrochloride
Pilocarpine 5 mg po qid x 4 weeks
|Placebo Comparator: Placebo||
Placebo 5 mg po qid x 4 weeks
OBJECTIVES: I. Evaluate the effectiveness of daily oral pilocarpine versus placebo in relieving dry mouth due to the ongoing use of an opioid for cancer related pain at 2 weeks by comparing proportion of patients with at least one response during the 2 week period, time of first response, and duration of first response. II. Evaluate the adverse effects of pilocarpine in these patients. III. Evaluate whether constipation, sedation, poor appetite, and nausea are ameliorated by pilocarpine in these patients. IV. Evaluate the effect of pilocarpine on quality of life of this patient group. V. Determine the timing and duration of the effect of pilocarpine in this patient population.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients receive either oral pilocarpine four times daily (arm I) or oral placebo four times daily (arm II) for 4 weeks. At the end of the 4 weeks, all patients are given the option to receive oral pilocarpine. Quality of life is assessed 2 days prior to randomization, after 2 weeks of treatment, and after 4 weeks of treatment.
PROJECTED ACCRUAL: There will be 60 patients accrued into this study within 18 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003686
|Canada, British Columbia|
|BC Cancer Agency|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Humber River Regional Hospital|
|Weston, Ontario, Canada, M9N 1N8|
|Study Chair:||David Warr, MD||Princess Margaret Hospital, Canada|