Pilocarpine in Treating Patients With Dry Mouth Caused by Opioids
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Oral Complications of Cancer and Cancer Therapy; Quality of Life
Intervention: pilocarpine hydrochloride (Drug); quality-of-life assessment (Procedure)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: National Cancer Institute of Canada Official(s) and/or principal investigator(s):
David Warr, MD, Study Chair, Affiliation: Princess Margaret Hospital, Canada
Summary
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.
Clinical Details
Official title: A Double Blind Phase III Study of Oral Pilocarpine for Opioid-Induced Dry Mouth
Study design: Supportive Care, Randomized
Detailed description:
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.
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS: Complaint of dry mouth with ALL the following characteristics: At
least 1 week in duration Attributed by the treating physician to an opioid Severity rating
at least 20 mm on a 100 mm visual analog scale Must be receiving routine (i. e., not just as
needed) dosing with one of the following opioids: morphine, hydromorphone, transdermal
fentanyl, methadone, or oxycodone Intent to continue opioid therapy at the same or higher
dose over the first 2 weeks that the patient is receiving protocol treatment
PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-3 Life expectancy: At
least 6 weeks Hematopoietic: Not specified Hepatic: Not specified Renal: Calcium less than
29. 9 mg/dL Cardiovascular: No symptomatic congestive heart failure or hypotension (systolic
blood pressure less than 100 mm Hg) Pulmonary: No obstructive pulmonary disease (asthma,
chronic bronchitis, or chronic obstructive pulmonary disease) Other: No known sensitivity
to pilocarpine No active oral candidiasis No Sjogren's syndrome No acute iritis or
narrow-angle glaucoma Not pregnant or nursing Effective contraception required of all
fertile patients Must be fluent and possess sufficient cognitive ability to complete
quality of life questionnaires in either English or French without assistance from a
caregiver
PRIOR CONCURRENT THERAPY: See Disease Characteristics Biologic therapy: Not specified
Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior
radiotherapy to a field encompassing the parotid glands At least 1 week since prior
radiotherapy to the chief site of pain No concurrent radiotherapy to chief site of pain for
2 weeks following randomization Surgery: Not specified Other: No concurrent tricyclic
antidepressants (amitriptyline, nortriptyline, desipramine, or imipramine)
Locations and Contacts
BC Cancer Agency, Vancouver, British Columbia V5Z 4E6, Canada
Humber River Regional Hospital, Weston, Ontario M9N 1N8, Canada
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: December 1998
Last updated: May 23, 2008
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