Sublingual methadone for the management of cancer-related breakthrough pain in outpatients

Not Applicable

Completed

• Conditions: Cancer-related breakthrough pain; Cancer; Pain, cancer

• Registration Number: ISRCTN61713542
• Lead Sponsor: Alberta Cancer Board (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-07-06
• Study Completion: 2007-12-31
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Patients aged 18 years and older are eligible if they have:
1. Pain due to cancer or its treatment
2. Controlled baseline pain
3. Episodes of breakthrough pain every day that are 4/10 in severity or greater, last ten minutes or longer, and are responsive to short acting oral opioids such as morphine or hydromorphone
4. Able to hold a volume of 1.0 cc of water under the tongue for a five minute period
5. Able to provide written, informed consent
6. Able to fill out the study forms

Exclusion Criteria

1. Severe underlying respiratory disease such that the investigator is wary about the risk of respiratory failure from modest doses of opioid
2. Prior sensitivity to methadone
3. Currently taking methadone
4. Breakthrough pain that in the opinion of the investigator is likely to change within the next seven days as a result of any of the following:
4.1. Recent or imminent radiation therapy to the main site of pain
4.2. New use of chemotherapy
4.3. Use of an injectable bisphosphonate likely to alter the pain
4.4. New use of corticosteroids within the past week with a corresponding change in pain
4.5. Other interventions judged likely to alter the pain
5. Are clinically unstable or have a life expectancy of less than one month making completion of the trial unlikely

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> To demonstrate the feasibility of a novel model to assess sublingual methadone to breakthrough pain in the outpatient setting. Specific aspects of feasibility are:<br> 1. To demonstrate the feasibility of recruitment to a study for incident pain in the outpatient setting<br> 2. Feasibility of dose titration in the outpatient setting<br> 3. Feasibility of filling out the pain assessments<br> 4. Provide preliminary evidence of efficacy<br> 5. Provide further information to document safety of the model<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. To develop a model of pharmacokinetic (PK) and pharmacodynamic (PD) study of breakthrough pain<br> 2. To develop a research tool, the Breakthrough Pain Assessment Tool (BPAT)<br> 3. To demonstrate proof of concept, with half of patients obtaining meaningful pain reduction within five minutes of administration, when given the identified optimal dose<br>