Pilocarpine in Treating Patients With Dry Mouth Caused by Opioids

• Status: Terminated
• Trial end date: 2008-12-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NCIC Clinical Trials Group
• Treatments: Pilocarpine

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)