A Double Blind Phase III Study of Oral Pilocarpine for Opioid-Induced Dry Mouth
16 Years
N/A
Both
Oral Complications, Quality of Life
Trial Information
A Double Blind Phase III Study of Oral Pilocarpine for Opioid-Induced Dry Mouth
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.
Inclusion 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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Outcome Measure:
Efficacy
Outcome Description:
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.
Outcome Time Frame:
10 years
Safety Issue:
No
Principal Investigator
David Warr, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Princess Margaret Hospital, Canada
Authority:
Canada: Health Canada
Study ID:
SC16
NCT ID:
NCT00003686
Start Date:
August 1998
Completion Date:
November 1999
Related Keywords:
- Oral Complications
- Quality of Life
- oral complications
- quality of life
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