Status:
TERMINATED
Sublingual Methadone for the Management of Cancer-related Breakthrough Pain in Outpatients
Lead Sponsor:
AHS Cancer Control Alberta
Collaborating Sponsors:
University of Calgary
Conditions:
Cancer
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this Phase II study is to determine the feasibility of the dose titration and assessment protocol in the outpatient population before conducting an appropriately powered phase III study...
Eligibility Criteria
Inclusion
- Pain due to cancer or its treatment; controlled baseline pain;
- episodes of breakthrough pain every day that are "4/10" in severity or greater, ;
- ast 10 minutes or longer, and
- are responsive to short acting oral opioids such as morphine or hydromorphone;
- are able to hole a volume of 1.0cc of water under the tongue for a 5-minute period; are able to provide written informed consent;
- are able to fill out the study forms
Exclusion
- Severe underlying respiratory disease such that an investigator is wary about the risk of respiratory failure from modest doses of opioid;
- prior sensitivity to methadone;
- currently are being administered methadone;
- have breakthrough pain that in the opinion of the investigator is likely to change within the next seven days (recent or imminent radiation therapy to the main site of pain,
- new chemotherapy or use of an injectable bisphosphonate likely to alter the pain, new use corticosteroids within the past week with a corresponding change in pain, or other interventions judged likely to alter pain);
- are clinically unstable or have a life expectancy of less than one month making completion of the trial unlikely
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00351715
Start Date
July 1 2008
End Date
September 1 2008
Last Update
October 21 2019
Active Locations (2)
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1
Tom Baker Cancer Center
Calgary, Alberta, Canada, T2N 4N2
2
Tom Baker Cancer Centre
Calgary, Alberta, Canada