NCT00003686

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 1998

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 1998

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.8 years until next milestone

First Posted

Study publicly available on registry

August 17, 2004

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2008

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

9.5 years

First QC Date

November 1, 1999

Last Update Submit

April 1, 2020

Conditions

Oral ComplicationsQuality of Life

Keywords

oral complicationsquality of life

Outcome Measures

Primary Outcomes (1)

  • Efficacy

    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.

    10 years

Study Arms (2)

Pilocarpine

ACTIVE COMPARATOR
Drug: pilocarpine hydrochloride

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

pilocarpine hydrochlorideDRUG

Pilocarpine 5 mg po qid x 4 weeks

Pilocarpine
PlaceboDRUG

Placebo 5 mg po qid x 4 weeks

Placebo

Eligibility Criteria

Age16 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

BC Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Humber River Regional Hospital

Weston, Ontario, M9N 1N8, Canada

Location

Related Publications (1)

  • Engelhardt M, Dold SM, Ihorst G, Zober A, Moller M, Reinhardt H, Hieke S, Schumacher M, Wasch R. Geriatric assessment in multiple myeloma patients: validation of the International Myeloma Working Group (IMWG) score and comparison with other common comorbidity scores. Haematologica. 2016 Sep;101(9):1110-9. doi: 10.3324/haematol.2016.148189. Epub 2016 Jun 16.

    PMID: 27479825DERIVED

MeSH Terms

Interventions

Pilocarpine

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic Compounds

Study Officials

  • David Warr, MD

    Princess Margaret Hospital, Canada

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 17, 2004

Study Start

May 22, 1998

Primary Completion

November 1, 2007

Study Completion

December 15, 2008

Last Updated

April 3, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)