Quality of Life Clinical Trial
Official title:
A Double Blind Phase III Study of Oral Pilocarpine for Opioid-Induced Dry Mouth
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.
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.
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